(Updated 7/17/20). Have you heard of the anti-aging supplement Protandim? Maybe you saw a YouTube video of when Protandim was featured on ABC's PrimeTime? Protandim called an “Nrf2 activator” has been said to be the “only supplement clinically proven to reduce oxidative stress in humans by an average of 40 percent in 30 days.” That’s fancy talk for Protandim is a type of antioxidant supplement. Unlike other products, Protandim is said to work by helping the body increase its own natural antioxidant enzymes. Sounds good, but does Protandim work, or is it a scam? These are some of the questions I will address in this review. The good news is there are clinical studies on Protandim. I will use that research in this review and help you understand it. By the end of this review, you'll have a better idea if Protandim is right for you.
Other Anti-Aging Supplement Reviews
What Is Protandim?
Protandim might sound like a drug but it's really a dietary supplement. It's said to combat free radical damage (oxidative stress) by stimulating the production of the body's own natural antioxidant enzymes such as catalase, superoxide dismutase (SOD), and glutathione.
The idea goes like this: instead of taking individual antioxidant supplements (like vitamins C, E, etc.) in the hopes they will battle free radicals and combat aging and disease, Protandim is supposed to augment or ramp up your own naturally occurring free radical defenses.
It's a novel concept to be sure.
The supplement website (LifeVantage.com) says the supplement is “clinically proven to reduce oxidative stress to levels of that of a 20-year-old.” Oxidative stress refers to the stress (cellular damage) caused by free radicals.
What Does The Name Mean?
My guess is the name was chosen because the ingredients are supposed to “pro-actively” work in “tandim” to help defend us against aging and disease.
Who Makes Protandim?
Protandim is a product of a company called LifeVantage Corporation. LifeVantage is actually a publicly traded stock on the NASDAQ. Its stock symbol is LFVN.
The company is located at 9785 S. Monroe Street, Suite 300 Sandy, UT 84070. If you google this address you will see a building with “LifeVantage” at the top. That is good. It tells us the company has a physical location.
Contact LifeVantage
Call the company at 866-460-7241.
The Better Business Bureau gave LifeVantage an A- rating when this review was updated. See the BBB file for updates and more information.
Protandim Ingredients
According to the product's website, there are 5 ingredients in each caplet of Protandim which add up to 625 mg:
Amount Per Serving (1 caplet) | Percent Daily Value |
---|---|
Calcium (as dicalcum phosphate & calcium carbonate) 77 mg | 8% DV |
Proprietary Blend Consisting of the following | 675 mg |
Milk thistle extract (Silybum marianum) seed. | |
Bacopa extract (Bacopa monnieri) whole herb | |
Ashwagandha extract (Withania somnifera) root | |
Green tea extract (Camellia sinensis) leaf | |
Turmeric extract (Curcuma longa) rhizome |
Notice in the table above they tell us the source of each ingredient:
- The milk thistle extract is derived from the seeds of the plant
- The bacopa extract is derived from the whole plant
- The ashwagandha extract is derived from the root of the plant
- The green tea extract comes from the leaves of the plant
- The turmeric extract is derived from the underground stems (rhizome) of the plant
Other Ingredients
The supplement label also tells the supplement has these other ingredients:
- Microcrystalline Cellulose
- Croscarmellose Sodium Silica
- Modified Cellulose
- Stearic Acid
- Magnesium Stearate
- Maltodextrin
- Medium Chain Triglycerides
These other ingredients play no role in the effects or benefits of the product. They make up the caplets and/or help with the delivery of the ingredients into the body.
I want to commend the LifeVantage company for sponsoring much of the research below. It's rare to find a product with so many clinical studies.
Protandim Research
Protandim is different from a lot of supplements because there really is clinical research on this product. Below is a summary of the Protandim research with links to the studies for those who want to see them for themselves.
Because scientific studies can be wordy and complicated for most people, I will summarize the study and put the research in the proper context to make it easier to understand.
2016 Protandim Research
Study
The Effect of Protandim® Supplementation on Athletic Performance and Oxidative Blood Markers in Runners.
Study summary: In this investigation, researchers tested if taking Protandim (675 mg/day) for 90 days would improve 5K running performance and reduce TBARS. The study involved 38 runners who were randomly given either Protandim or a placebo.
Results: After 90 days, those taking Protandim (1x/day) showed no improvement in running performance compared to those taking the placebo. In addition, Protandim did not reduce TBARS or alter levels of antioxidant enzymes superoxide dismutase (SOD) or glutathione peroxidase (GPX) during resting periods. The researchers report however that in those over age 35, Protandim improved SOD twice as much as those taking the placebo.
See the full review of this study
Study
Longer lifespan in male mice treated with a weakly estrogenic agonist, an antioxidant, an α-glucosidase inhibitor or an Nrf2-inducer.
Study summary: Here, researchers sought to determine what effect various compounds had on extending the life of mice. Protandim was one of the compounds tested. The other compounds tested in the study were fish oil, ursodeoxycholic acid (a bile acid, used to dissolve gall stones), and the diabetes drug, metformin. Different mice received the different compounds for their entire lifespan.
Beginning at 10 months of age, mice received Protandim at a dosage of 600 parts per million (ppm) in their food. This amount was chosen because it was similar to the Protandim dosage used by people. When the mice were 17 months old, the dosage was increased to 1200 ppm because this was thought to be better.
Study results: researchers noted male mice getting Protandim had a 7% increase in average lifespan. The supplement did not lengthen the life span of female mice. The researchers also point out that while the average lifespan was increased, the maximum lifespan did not increase. Regardless, this was a mouse study.
2013 Protandim Research
Study
Study
Upregulation of phase II enzymes through phytochemical activation of Nrf2 protects cardiomyocytes against oxidant stress
Study results: Researchers noted that mouse heart cells treated with Protandim increased the production of an antioxidant/anti-inflammatory enzyme called Heme oxygenase 1 (HO-1) as well as Nrf2. This was a test-tube study using isolated mouse heart cells.
This investigation is derived from a Masters's Thesis in 2010. The title of the MS Thesis is “UPREGULATION OF HEME OXYGENASE-1 AND ACTIVATION OF NRF2 BY THE PHYTOCHEMICALS IN PROTANDIM .” It is not unusual for a quality MS thesis or other graduate work to go through the peer-review process and be published.
2012 Protandim Research
Study
Antioxidants for the Treatment of Patients with Severe Angioproliferative Pulmonary Hypertension? Published in the journal, Antioxidants in Redox Signaling.
Summary: This is a rat study. Protandim increased antioxidant enzymes in rats, protecting the hearts from damage.
Study
Phytochemical activation of Nrf2 protects human coronary artery endothelial cells against an oxidative challenge published in the journal, Oxidative Medicine and Cellular Longevity.
Summary: This is a test tube study. Human coronary (heart) artery cells were treated with Protandim (20 micrograms per milliliter) or placebo (ethanol). All cells were then treated with hydrogen peroxide (H2O2) to induce free radical damage. Cells treated with Protandim showed less cell death than those getting the placebo.
Study
Protandim does not influence alveolar epithelial permeability or intrapulmonary oxidative stress in human subjects with alcohol use disorders.
Summary: This investigation showed the supplement did not work. To be fair, this was a strange study. Researchers looked at 30 alcoholics . The researchers stuck tubes down the throats of the subjects to take fluid samples from their lungs. They randomly gave the people 1350 mg of Protandim per day or a placebo, for a week. They tested for various things to see if Protandim helped the people. It didn’t.
I don't know how relevant this study is to whether Protandim works or not. I mentioned it because it was a human study. For a much more in-depth review of this study—written by a doctor—see the review posted on ScienceBasedMedicine.org.
2011 Protandim Research
Study
Oxidative stress in health and disease: the therapeutic potential of Nrf2 activation.
Summary: This is a test tube study. Essentially, Protandim altered cellular pathways involved in antioxidant enzyme production and colon cancer, cardiovascular disease (heart disease), and Alzheimer's disease. This is encouraging, but, humans are more complicated than isolated cells. This study doesn’t prove the supplement reduces the risk of any of these diseases.
Study
The role of manganese superoxide dismutase in skin cancer.
Summary: This is a mouse study. Here, researchers reported the supplement reduced tumor growth in mice. For the most part, this appears to be a review of previous research relating free radical damage to the development of skin cancer.
Study
Protandim attenuates intimal hyperplasia in human saphenous veins cultured ex vivo via a catalase-dependent pathway.
Summary. This is a test tube study. Basically, a blood vessel was bathed in Protandim. Researchers noted the supplement reduced the thickening of vein cells.
2010 Protandim Research
Study
The Dietary Supplement Protandim Decreases Plasma Osteopontin and Improves Markers of Oxidative Stress in Muscular Dystrophy Mdx Mice.
Summary. This is a mouse study. Mice were genetically created to have muscular dystrophy. They were given Protandim at a dosage similar to what is recommended for humans. After 6 months, the mice given Protandim showed a 46%reduction in the free radical breakdown of fat (TBARS). TBARS stand for ThiobarBituric Acid Reactive Substances.
The greater the TBAR level, the greater free radical damage. Thus, reducing TBARS is taken to be a good thing. This doesn't prove Protandim helps muscular dystrophy. People with muscular dystrophy should discuss this with their doctor for greater insights.
Study
The chemopreventive effects of Protandim: modulation of p53 mitochondrial translocation and apoptosis during skin carcinogenesis.
Summary: This is a mouse study. Protandim reduced damage to the mitochondria of mouse cells. of this study. The mitochondria, often called the “powerhouse” of the cell, make energy —and makes free radicals in the process. The mitochondria are a major area of anti-aging research.
Study
Chronic pulmonary artery pressure elevation is insufficient to explain right heart failure.
Summary. This is a rat study. Researchers tested if the supplement helped pulmonary blood pressure. After 6 weeks, Protandim did not reduce pulmonary artery blood pressure or the number of lung lesions. These researchers did say “our data point to a cardioprotective effect of Protandim.” But, this is a vague statement.
2009 Protandim Research
Study
Protandim, a fundamentally new antioxidant approach in chemoprevention using mouse two-stage skin carcinogenesis as a model.
Summary: This is a mouse study.
Study
Synergistic induction of heme oxygenase-1 by the components of the antioxidant supplement Protandim.
Summary: This is a test tube study. Cells treated with supplements showed significant increases in glutathione, an antioxidant compound. This is the study LifeVantage lists as “proof” Protandim increases glutathione levels by 300%. It may raise glutathione 300% – in a test tube – but does the same effect occur in people?
2006 Protandim Research
Study
The induction of human superoxide dismutase and catalase in vivo: a fundamentally new approach to antioxidant therapy.
This is a human study. 39 healthy men and women, age 20-78 years were given Protandim (675 mg per day) between 30 and 120 days.
Study Summary:
1. Protandim caused a significant increase in the antioxidant superoxide dismutase (SOD) in red blood cells.
2. TBARS declined by 40% after 30 days
3. SOD in red blood cells increased by 30% after 120 days
4. Catalase decreased by 40% after 120 days
5. There was a non-significant rise (4.9%) in uric acid.
6. No change in CRP levels was seen.
7. No change in HDL, LDL or triglycerides were seen.
Protandim Research Summary
Here is a quick summary of the research:
Study Year / Title | Study Type (Human, mouse, etc.) |
2016 Research | |
The Effect of Protandim Supplementation on Athletic Performance and Oxidative Blood Markers in Runners | Humans |
Longer lifespan in male mice treated with a weakly estrogenic agonist, an antioxidant, an α-glucosidase inhibitor or a Nrf2-inducer | mice |
2013 Research | |
Upregulation of phase II enzymes through phytochemical activation of Nrf2 protects cardiomyocytes against oxidant stress | Mouse heart cells |
2012 Research | |
Antioxidants for the treatment of patients with severe angioproliferative pulmonary hypertension? | Rats |
Phytochemical Activation of Nrf2 Protects Human Coronary Artery Endothelial Cells against an Oxidative Challenge | Test tube study |
Protandim does not influence alveolar epithelial permeability or intrapulmonary oxidative stress in human subjects with alcohol use disorders. | Humans |
2011 Research | |
Oxidative stress in health and disease: the therapeutic potential of Nrf2 activation. | Test tube study |
The Role of Manganese Superoxide Dismutase in Skin Cancer | Mice |
Protandim attenuates intimal hyperplasia in human saphenous veins cultured ex vivo via a catalase-dependent pathway | Test tube study |
2010 Research | |
The Dietary Supplement Protandim® Decreases Plasma Osteopontin and Improves Markers of Oxidative Stress in Muscular Dystrophy Mdx Mice | Mice |
The Chemopreventive Effects of Protandim: Modulation of p53 Mitochondrial Translocation and Apoptosis during Skin Carcinogenesis | Mice |
Chronic Pulmonary Artery Pressure Elevation Is Insufficient to Explain Right Heart Failure | Rats |
2009 Research | |
Protandim, a Fundamentally New Antioxidant Approach in Chemoprevention Using Mouse Two-Stage Skin Carcinogenesis as a Model | Mice |
Synergistic induction of heme oxygenase-1 by the components of the antioxidant supplement Protandim. | Test tube study |
2006 Research | |
The induction of human superoxide dismutase and catalase in vivo: a fundamentally new approach to antioxidant therapy. | Humans |
To be fair, it's possible I may have missed some research. I'll update this table as I become aware of new research.
My Thoughts On The Research
While Protandim has been the subject of several clinical investigations, only 3 of them involved humans. They are:
- The 2006 study (click to see study)
- The 2012 study (click to see study)
- The 2016 study (click to see the study)
Protandim And Weight Loss
Can Protaindm help you lose weight? There is no good evidence for this. None of the above clinical investigations was about weight loss. To the credit of LifeVangage, they do not market this supplement for weight reduction.
Protandim And Multiple Sclerosis
Is this supplement worthwhile if you have Multiple sclerosis (MS)? Some have put forth the idea that disruption of free radical stress – via stabilizing Nrf2 (the stuff this supplement is supposed to improve) – might help MS. So, is there any proof? There was an investigation presented in 2011 at the 5th Joint triennial congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis Amsterdam, The Netherlands.
The title of the presentation was: Nrf2 activators: a novel strategy to promote oligodendrocyte survival in multiple sclerosis? Here, researchers treated rat and human oligodendrocytes with several compounds ― one of which was Protandim ― and then exposed the cells to a chemical to create free radical damage.
These researchers noted Protandim was seen as “the most potent inducer” of Nrf2 antioxidant enzymes defenses. In other words, Protandim helped the most.
This is intriguing, but it's not the same as giving it to people with MS to see if their symptoms improved.
There is also some evidence that stimulating Nrf2 might reduce cellular inflammation via inhibition of NFkb. Inhibition of NFkb is also something another supplement – called Anatabloc – was supposed to do. Currently, though there is little human proof for Protandim improving quality of life in those with MS.
See the Anatabloc review.
Protandim And ABC Primetime
In 2005, this supplement was featured on ABC's Primetime news show. In this segment, ABC correspondent John Quinones met with Dr. Joe McCord, a respected researcher whose name appears on many of the Protandim clinical studies. According to his Wikipedia page, as a grad student, Dr. McCord was involved with the discovery of Superoxide Dismutase, an important free radical savaging enzyme. Here is the ABC Primetime segment :
Basically, John Quinones gets a blood test to measure his TBAR level (an indicator of oxidative stress). He's given Protandim for 2 weeks and then returns to the lab where he has his blood tested again.
Dr. McCord tells John Quinones the supplement caused a “45% reduction” in oxidative stress and goes on to say this is the level seen in a “newborn baby”. The ABC Primetime segment is often used as proof the supplement really works. But, as I see it, one problem is John Quinones doesn't have is blood tested by an independent lab. This is bad science in my opinion.
Of course, the Primetime segment is interesting. But it's been over a decade since this segment aired. You'd think such an impressive result would warrant a follow-up. I wish Primetime and John Quinones would do a follow-up story.
Update. Dr. McCord is now involved with the PB125 supplement.
Protandim And The FDA
In 2017, the FDA reached out to LifeVantage to inform them they considered Protandim to be a drug and not a supplement based on claims made about it as an NRF2 Synergizer. Basically, the FDA was saying the claims being made at the time, made people think the supplement could treat disease. This is something not allowed under US supplement regulation. This may be the reason for the dramatic change in the LifeVantage website and marketing. There are no more claims about the effects of the supplement. Instead, the company now calls itself “a wellness and personal care company” and makes references to “bio-hacking.”
Do Doctors Endorse Protandim?
While the supplement is not endorsed by the American Medical Association (they don't endorse any supplement), I'm sure some physicians believe in it – and others who don't.
Does Protandim Have Caffeine?
According to the product website, each tablet has 1.8mg of caffeine. That's much less than in a cup of coffee and most energy drinks. I don't think this small amount would keep people up at night, but because we are all different it might be wise to not take it close to bedtime.
Is It Kosher?
No. this supplement is not kosher or organic. It is however made in the US. That is good.
Protandim Side Effects
Are there any Protandim dangers out there? I don't think so. I believe this supplement is pretty safe. I am not aware of any side effects. That said, here are a few general things you might want to think about if your not healthy. This list is not complete:
- Start with less than the recommended dosage for the first week to see how you respond
- Speak to your doctor/ pharmacist if you are pregnant or breastfeeding
- Stop taking the supplement at least 2 weeks before having surgery
- Speak to your doctor /pharmacist if you take any prescription drugs like blood thinners
One study noted the supplement might raise uric acid levels (by 4.9%). Would this be bad for those who suffer from gout? Currently, there is no direct proof gout pain is increased by Protandim. See the review of Tart Cherry Juice for more info.
While allergic reactions are likely uncommon, LifeVantage does mention this possibility in some people. Specific symptoms mentioned on the LifeVantage website include:
- gastrointestinal disturbances (i.e., stomach ache, diarrhea, vomiting)
- sometimes as a headache or rash on the hands or feet
Stop taking the supplement if you experience these symptoms.
The company website warns against using the supplement if you are undergoing chemotherapy or radiation therapy for cancer. This is likely because of the unknowns of combining antioxidants with some cancer therapies. If you have cancer or are getting treatment for it, ask your doctor. I'm glad the LifeVantage company informs people about this.
LifeVantage also stresses the importance of talking to a doctor if you have any autoimmune disease like arthritis or Type I diabetes. I'm not aware of any problems in anyone but I appreciated the company mentioning this.
How To Measure Your TBARS
Remember TBARS are a measure of free radical damage (oxidative stress) of cells. Protandim is said to reduce TBARS. The TBAR test is also called a Lipid Peroxidase test. Ask your physician about this test. For those who really want to know if Protandim is working, getting this test done first—and a month later— might be a good idea. I'm not sure if insurance covers the test or not. Talk to your doctor for more information on this.
Aged Garlic Extract also has some evidence it might reduce TBARS (click to see review)
TrueScience Brand
True Science is a brand name under which various beauty products made by the company can be identified. Products offered under the True Science brand include:
- Shampoo
- Scalp serum
- Facial cleanser
- Eye serum
What is PhysIQ?
PhysIQ is the brand name associated with various fitness-related products. This brand includes:
- Fat burn supplements
- Prebiotics
- Whey protein
- Appetite suppressants
Protandim For Dogs
Protandim Dogs (formally called Canine Health) is for pets. According to the LifeVantage website, this supplement contains 150 mg of the same ingredients as Protandim – as well as omega 3 fatty acids and collagen. The website goes on to say: “Reducing oxidative stress in dogs may reduce many of the disorders associated with aging in canine.” To support this, the organization states a 3rd party animal health company has found the supplement reduces oxidative stress in dogs.
Protandim vs. PB125
PB125, by Pathways Bioscience, is another supplement whose makers claim can reduce TBARS and activate NrF2. PB125 is the supplement by Dr. Joe McCord and associates. Recall Dr. McCord used to be associated with the LifeVantage company.
While PB125 is said to be the next generation of NrF2 activators, no studies have yet compared these supplements to each other to see which is better. The ingredients in both products are different for the most part.
See the PB125 Review for much more information.
Protandim vs. Tru Niagen
The Tru Niagen supplement boasts research showing it can raise NAD+ levels in humans. Tru Niagen is based on nicotniamide riboside a form of niacin (vitamin B3).
The idea of slowing aging by raising NAD+ is different than Protandim. So far no clinical studies have compared these supplements to each other. While the original Protandim does not contain nicotinamide riboside, the Life Vantage company does offer another version called the “NAD Synergizer” which contains niacin.
Protandim vs. Elysium Basis
Basis by Elysium is a popular anti-aging supplement that contains very different ingredients than Protandim. Like Tru Niagen, Elysium Basis also is an NAD+ booster supplement. So, which is better? Unfortunately, there are no head-to-head studies yet.
See the Elysuim Basis Review for more insights.
Protandim vs. SeroVital
You've probably seen TV ads for SeroVital. How does Protandim compare to SeroVital? Both supplements contain different ingredients and are touted to work differently.
While Protandim is said to help boost our bodies antioxidant enzymes, SeroVital is marketed to raise human growth hormone (HGH).
If we just look at the research, Protandim wins hands down. The makers of Serovital only have one study.
Where To Buy Protandim
This supplement is not sold in stores like Walmart, Target, Cosco, CVS, Walgreens, Kmart, or BJs. It's also not sold at GNC or Vitamin Shoppe. Rather, it's mostly purchased from LifeVantage independent distributors.
It is also available online as well although when using a distributor, you may get the individualized attention you might not get by buying it yourself.
Protandim Price
According to the LifeVantage website, a one-month supply (30 capsules) costs $59.99 retail. If you order it through a LifeVantage distributor, it costs $49.99 – and that is on a monthly basis. In other words, that means auto-shipments. If you want to purchase one month only to test drive it first, speak to your LifeVantgage independent distributor.
Protandim Yearly Cost
Let's round the price up to $50 a month. In one year, the supplement would cost you $600. Shipping and tax may be extra. If you only want to order 1 bottle to try yourself, you can get it on Amazon too.
My Suggestions
If you can afford it, go ahead and give it a try for a month or so and see if you feel any better. If you really want to know for sure, get your TBARS measured first.
Remember, exercise will also reduce TBARS too.
Protandim Pro & Con
Here's a quick summary of what I liked and didn't like. These are my opinions. Yours may be different.
Pro | Con |
---|---|
There are clinical studies on Protandim | Not all the studies are on humans |
Company has been around a long time | Not available in stores |
Company sponsors research on Protandim | Expensive |
Lots of hype about benefits |
Does Protandim Work?
While I'm intrigued at the prospect of slowing down aging, I'm can't say for sure if Protandim works or not. The research is intriguing but in my opinion three's not enough human research yet to draw conclusions. So, does Protandim really work? Let's just say I'm looking forward to more human clinical studies.
Here is it is on Amazon If you want to check it out/see what others are saying
Vogel says
Some of SG’s readers might not know the meaning of clinical research jargon like endpoints, p-hacking, data mining, moving goal posts, etc., or why it’s so critical for all study endpoints and analyses to be pre-specified before a clinical trial begins.
Endpoints are the parameters that a clinical trial sets out to investigate based on a specific hypothesis. There are two types: primary and secondary. A primary endpoint is a single very specific measurable parameter that is the overarching focus of the study and the sole criteria by which “success” or “failure” of the test agent is defined. Secondary endpoints are typically a small group of additional parameters that are of lesser interest and do not define success or failure. So in other words, if a test agent doesn’t achieve a pre-specified primary endpoint, it is deemed to have failed.
The other terms I mentioned all refer to cheats that can be used to make bad/negative data look better. Moving goalposts essentially means changing endpoints after the study has been completed. Terms like data mining, fishing expedition, and p-hacking are used to describe a particular type of breech of statistical protocol.
Imagine a scenario where an investigator completes a study testing the effect of a new drug on serum LDL, and the pre-specified primary endpoint is a statistically significant difference in absolute serum LDL levels after 1-year treatment with Drug X versus a placebo). But the investigator upon analyzing the data learns that there was no difference in LDL levels (expressed as mmol/L) between the drug and placebo groups at Year 1, and thus a dilemma arises — journals don’t usually publish studies with negative results, and the company that gave the investigator a pile of money can’t promote their product with negative data.
So what to do? No problem, says the investigator, just change the endpoint (i.e., move the goalpost) to the difference (in mmol/L) between the LDL values at Day 0 and Year 1, instead of analyzing the final LDL level at year 1, and see if that turns out to be different; and if that doesn’t work, maybe try exaggerating a very trivial effect on LDL levels by converting it to a percentage of the value at Day 0 instead of the difference in mmol/L. If that doesn’t work, maybe change the analysis to LDL levels at month 6 instead of year 1, or look at something else entirely different like serum HDL or total cholesterol, or triglycerides.
If none of those cheats yield the desired results, then just analyze a hundred different parameters because surely that will yield at least one parameter that differs between the drug and placebo groups (i.e., data mining, fishing expedition, p-hacking). Then when you find some parameter that shows a difference (although by chance alone), you can report that as a significant result and bury the negative results, maybe even by pretending that you never even considered measuring it.
After that explanation, you might still be left wondering why it’s wrong to change endpoints or probe numerous endpoints after the fact, or even what “statistical difference” means. In short, statistical tests are used to determine whether one set of data is truly “different” from another set of data (e.g., the “difference” between drug and control groups).
Imagine an experiment where we test to see if there’s a difference in resting systolic blood pressure between men and women by taking BP cuff measurements in 10 men and 10 women. We describe the data by using the average SBPs for each of the two groups and compare them to see if they are different. Let’s say the average is 130 for the males and 120 for the females. Do you conclude that men have higher BP than women?
Now imagine that the data in both groups was “noisy” (spread all over the place) and one of the guys threw off the average for the male group because he had hypertension and the rest of the subjects didn’t. This dilemma of how to compare datasets and noisiness is where statistical tests come in; they not only compare averages, they take into consideration the variability (spread and overlap) of the data, which is typically expressed as standard error of the mean (SEM) or standard deviation (SD). Common statistical tests used to compare averages and noisiness of datasets include the T-test and ANOVA (analysis of variance), both of which generate something called a p-value, which is essentially the probability that two or more datasets (or averages) are actually different from one another (well, really, it’s the probability that a difference occurred by random chance, but we’ll stick with the simpler definition for now).
A useful thought exercise for understanding p-values is a simple coin toss paradigm. If we toss once and get heads, we’re not surprised, because the odds are 50/50 (1 in 2). Same if we hit heads 3 times in a row, because the odds are still pretty high that this will happen fairly often by random chance alone. But if we hit 10 heads in a row (1/1024 odds) we might suspect that this probably isn’t random chance alone but maybe a weighted coin. However, if we get 10 heads in a row once after flipping 1024 times, we wouldn’t be surprised at all because that would match exactly with the odds of achieving such a result.
P-values are essentially the probability criteria that statisticians set to define when a result (i.e., difference between groups), analogous to tossing heads a certain number of times in a row, is unlikely to be due to random chance alone. A p-value of 0.05 is pretty much the universal standard, which basically translates to a 1/20 (5%) chance that a given difference is due to random chance alone. If a p-value is lower than 0.05, then it means that a given difference is “statistically significant”; i.e., sufficiently unlikely to have occurred by random chance alone.
On a side note, another useful concept to understand is “statistical power”, which basically refers to the number of study subjects or measurements that would be required to reliably detect a difference of a given size for a specific parameter. That is, a larger subject population (or more measurements) would be required to reliably detect small effects, while larger effects would require fewer subjects. Using the coin flip experiment analogy, you wouldn’t expect to be able to detect a weighted coin by flipping only once, but flipping 20 times or more would likely offer sufficient statistical power.
So now, let’s take what we’ve just gone over and tie it back to p-hacking. Remember that the probability of flipping heads 10 times in a row on your first try is very low (1/1024), but that you are likely to do it once after flipping 1024 times. P-hacking is like flipping 1024 times. If you pick one primary endpoint in a study, the odds of finding a statistically significant difference (i.e., a p-value less than 0.05) in that parameter by random chance alone is fairly low (1/20) but if you pick 20 endpoints to analyze, you are likely to find a difference (p < 0.05) in one of them by random chance alone. Pick 100 endpoints and you’re almost certain to find differences by random chance alone.
This is why you can’t move goalposts, go on data mining and fishing expeditions, or resort to p-hacking. It’s also the very reason that ClinicalTrials.gov is such a boon for scientific transparency. When investigators pre-specify their study endpoints and statistical methods and list them on CT, they can’t go back after the data has been analyzed and move the goalposts. They can’t bury bad data by pretending that they never intended to measure the endpoint that yielded it. They can’t implement study designs that specify a ridiculous number of endpoints and engage in p-hacking because review boards don’t approve protocols with faulty statistical plans, and good journals don’t publish studies that employ them. That’s why every clinical trial should be registered on CT, and why the top tier journals demand it as a prerequisite for publication.
Zavorsky registering the Protandim runner study on CT was what ultimately cooked LifeVantage’s goose because it forced the authors to highlight that (a) LifeVantage insisted on adding a new endpoint analysis after the results for the original endpoints were found to be negative, and (b) doing so entailed p-hacking and was invalid. The original endpoint for SOD was a significant change in the total study population, regardless of age. LifeVantage violated the statistical protocol by including, after the fact, an analysis of SOD levels in an arbitrarily created subgroup of subjects who were 35 years of age or older.
Hope this helps readers to better understand what’s up with the Protandim runner’s study. Hit me back if you have any questions.
LisaRob says
Thanks for taking the time to explain all of that, Vogel! Very helpful information, as always, from you.
Vogel says
Always a pleasure LisaRob. Glad you found it useful.
Leslie says
I just attended a Protandim marketing “party” and it concerned me that the main part of the presentation was the ABC Primetime show that was recorded in 2005. In trying to find any recent research and/or data, I found this website and your comments.
Thank you so much for your thorough and readable explanation of the research protocol. I was skeptical about the product to begin with, now I can save $40 a month!
Joe says
Hi Leslie, thanks for sharing. I wish ABC Primetime would do a follow up to their 2005 segment.
Vogel says
I just went through LifeVantage’s product FAQ sheet on Protandim and was horrified to see that pretty much every claim in it was either misleading or blatantly false. Below is a summary of the most egregious examples.
FAQ: “Protandim…is the subject of 20 peer-reviewed clinical studies.”
http://www.lifevantage.com/wp-content/uploads/2016/04/US-Protandim-FAQs-V.03.pdf
Nope. A clinical study is defined as a study in live intact humans.
http://www.nhlbi.nih.gov/studies/clinicaltrials
Only 3 “clinical studies” on Protandim have been published; not 20. The latter two, unlike the first study (by Nelson et al. Free Radical Biol Med 2006), were double-blind, randomized, and placebo-controlled and they both showed that the product did not do anything.
http://www.ncbi.nlm.nih.gov/pubmed/27513339
http://www.ncbi.nlm.nih.gov/pubmed/22268125
FAQ: “Protandim Nrf2 Synergizer works to support the body’s own protective measures by turning on its internal antioxidant defense system, regulated by the protein Nrf2.”
LifeVantage has published precisely zero data showing that the product upregulates NRF2 in people who take the product.
FAQ: “At LifeVantage, we perform pesticide, herbicide and heavy metal testing on every lot of raw material to assure we have only safe, high quality products.”
If they do any testing at all, it’s apparently done very sloppily. In 2012 and 2013, the company issued two notices recalling more than a quarter million bottles of Protandim due to potential health risks arising from the inclusion of metal fragments, which cost them $5.9 million.
https://en.wikipedia.org/wiki/Protandim#Voluntary_recall
FAQ: “LifeVantage rigorously tests every lot of active raw material for identity, potency, microbial contamination, pesticides and heavy metals. Unlike most dietary supplement companies, we also physically audit all of our active raw material suppliers. We perform exhaustive testing to verify that all materials meet or exceed quality specifications.”
So rigorous that they had to spend $5.9 million to recall more than a quarter million bottles of product due to metal shard contamination.
FAQ: “Q: Can I take these ingredients individually and achieve the same effect? A: No, the individual ingredients in Protandim Nrf2 Synergizer aren’t as effective in activating the Nrf2 pathway as LifeVantage’s botanical blend.”
We know the recipe. It’s a 3:2:2:1:1 blend of extracts of milk thistle (225 mg), bacopa (150 mg), ashwagandha (150 mg), green tea (75 mg) and turmeric (75 mg) – all of which are dirt cheap ingredients. There’s no reason that a consumer couldn’t buy these individual ingredients and make their own identical blend at a minuscule fraction of the cost. The actual cost of the ingredients is negligible (probably in the neighborhood of a dime per pill). The real reason the product is so absurdly expensive is the MLM/pyramid distribution scheme; i.e., over the past few years, roughly 60% of the company’s gross profits went towards paying commissions and incentives to distributors.
https://www.sec.gov/Archives/edgar/data/849146/000084914615000098/lfvn_06302015x10k.htm
FAQ: “The FDA closely monitors the marketplace for illegal products (products that may be unsafe or make misleading claims) in a variety of ways, including inspections of dietary supplement manufacturers and distributors, dietary supplement websites, consumer complaints, and occasional laboratory analyses of products.”
The FDA does not “closely” monitor the supplement marketplace. They typically investigate and respond to illegal supplement marketing (and tainted or otherwise dangerous products) only after they have received complaints from consumers.
http://www.health.harvard.edu/blog/fda-needs-stronger-rules-to-ensure-the-safety-of-dietary-supplements-201202024182
http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/dietarysupplements/dietary-supplements-fda-regulations
http://ajcn.nutrition.org/content/85/1/323S.short
Supplement companies are required to report to the FDA all reports of serious adverse events received from consumers, but there is no enforcement mechanism to ensure that this happens, and supplement companies have been known to purposely hide such reports from the FDA. This is what Metabolife did, which resulted in their execs getting thrown in jail. And lo and behold, where did Metabolife’s CEO David Brown end up after that sordid fiasco? At the helm of LifeVantage!
https://en.wikipedia.org/wiki/Metabolife
And who did LifeVantage hire to manufacture Protandim? None other than the infamous Chemins Co., the same company that produced Metabolife — the product that was responsible for the numerous reports of injuries/deaths that were hidden from the FDA by the company’s execs.
https://en.wikipedia.org/wiki/Chemins
FAQ: “Protandim Nrf2 Synergizer is certified by NSF International.”
A certification from NSF is worse than worthless, given that NSF certifies mainly sketchy MLM supplement products. The only certification that carries any real weight is United States Pharmacopeia (USP) certification, which Protandim does not have.
http://info.nsf.org/Certified/Dietary/Listings.asp?StandardExt=&TradeName=&CompanyName=&PlantCountry=&ProductType=&search=Search
http://www.usp.org/dietary-supplements/overview
FAQ: “We do not expect there to be any side effects for the typical Protandim Nrf2 Synergizer consumer.”
The worst of all. The study in runners published in 2016 shows 5 types of side effects that each occurred in a quarter to a third of all subjects who took the product, and at a rate more than twice that of the placebo group. These included stomach ache, diarrhea, headache, nausea, and dizziness.
http://www.ncbi.nlm.nih.gov/pubmed/27513339
FAQ: “That’s where Protandim Nrf2 Synergizer plays a critical role by boosting the body’s production of antioxidant enzymes at the cellular level with enough neutralizing capacity to reduce age-related increase in free radical damage.”
Results from two of their studies contradict this statement. The product had no significant overall effects on antioxidant defenses (i.e., SOD) or free radical damage (i.e., TBARS).
http://www.ncbi.nlm.nih.gov/pubmed/27513339
http://www.ncbi.nlm.nih.gov/pubmed/22268125
FAQ: “As a Nrf2 activator, Protandim Nrf2 Synergizer helps keep the body safe from free radicals and oxidants by activating these survival genes.”
Protandim has never been shown to upregulate NRF2 or alter expression of “survival genes” in people who take the product. Two studies show that it doesn’t “keep the body safe from free radicals” – it did nothing.
LisaRob says
Vogel,
Have you looked at Lifevantage’s “Nrf2Science” website? The page on cancer uses quotes from studies on Protandim to promote the product. They substitute “Product 5X” for “Protandim,” I suppose to try and avoid legal issues.
Vogel says
LisaRob said: “Vogel, have you looked at Lifevantage’s “Nrf2Science” website? The page on cancer uses quotes from studies on Protandim to promote the product. They substitute “Product 5X” for “Protandim,” I suppose to try and avoid legal issues.”
Yeah that website is bizarre.
http://www.nrf2science.com/
What’s really strange about the site is that it contains a copyright notice at the bottom right of the homepage that says “LifeLine Nutraceuticals Corporation 2016”. Lifeline was the former name of LifeVantage until it was changed sometime around 2006, so it’s bizarre that they would use this defunct name on the webpage. It had me expecting that the owner of the site would be anonymously registered, but no; it is clearly registered to LifeVantage (and the contact listed is Matt Armstrong, LifeVantage’s director of infrastructure).
http://www.networksolutions.com/whois/results.jsp?domain=nrf2science.com
https://www.linkedin.com/in/matt-armstrong-9807195b
You are right that the product referred to as “5X” is in fact Protandim, since the studies they quote are Protandim studies.
http://www.nrf2science.com/cancer/
The site even has a page called “Canine Health”, which happens to be the trade name of LifeVantage’s supplement for dogs, and that page has a link to a research poster that unambiguously identifies the product as LifeVantage’s Canine Health supplement.
http://www.nrf2science.com/canine-health/
http://www.nrf2science.com/wp-content/uploads/2015/05/Canine-Health-Poster.pdf
The site apparently violates US law by implying that LifeVantage’s products are safe and effective for the prevention, treatment, or mitigation of diseases and/or their symptoms. That LifeVantage would do this so blatantly is really mystifying, but what I find most inexplicable, legal issues aside, is why they would put together such a painfully low-quality unprofessional website.
I strongly suggest that everyone notify the FDA about this site by filing an anonymous online complaint. It’s so easy and it’s a civic duty.
http://www.fda.gov/Safety/ReportaProblem/ucm059315.htm
Vogel says
So let’s recap a few key details about the 2016 Protandim study in runners by Ueberschlag et al. The study’s lead author Ueberschlag held only a bachelor’s degree at the time the work was conducted She conducted this work as part of a LifeVantage-funded Master’s thesis, published in 2015, which showed that Protandim had zero effect on any of the parameters studied.
http://ir.library.louisville.edu/cgi/viewcontent.cgi?article=3262&context=etd
Her thesis supervisor, Gerald S. Zavorsky, one of the other authors of the study, was also funded by LifeVantage, and inexplicably also served as one of the research subjects in the study, as indicated in the acknowledgements section of the article, in apparent violation of the study’s protocol for subject recruitment. According to his faculty page, he received at least $165,000 from LifeVantage
http://snhp.gsu.edu/profile/gerald-stanley-zavorsky/
Inexplicably again, Zavorsky took credit as lead author in a research abstract of this exact same study published in April 2016, while Ueberschlag was demoted to second author. This abstract, like the thesis, also reported that Protandim had no significant effect on any of the parameters studied. http://www.fasebj.org/content/30/1_Supplement/898.5?cited-by=yes&legid=fasebj;30/1_Supplement/898.5
The study protocol had been registered with ClinicalTrials.gov as of June 2014.
https://clinicaltrials.gov/ct2/show/NCT02172625
Registering in the ClinicalTrials.gov database is a step taken to ensure fair conduct of research – i.e., the exact protocol and endpoints are pre-specified so that if the results turn out to be negative, the researchers can’t go on a “data mining” expedition or “move the goalposts” post facto.
But this is in fact exactly what LifeVantage did when they foisted a sub-analysis of SOD levels in red blood cells of subjects over 35 years of age, which was not pre-specified in the protocol. In other words, they cheated, and the authors of the 2016 study confessed to the cheat, as follows:
“LifeVantage had no role in study design or data collection. They did, however, have access to the de-identified raw data of which an independent statistician hired by them verified our analyses. In a sub-analysis that their statistician performed, they showed that SOD increased in subjects equal to and greater than 35 years of age. While age related changes in SOD with supplementation was not made a priori, we added the results to the manuscript and discuss the ramifications of performing unplanned statistical tests in the manuscript. LifeVantage also received the manuscript draft as per agreement and provided some suggestions for improvement. GSZ accepted some of their suggestions on improvement, including the reporting of the unplanned age-related changes in SOD with supplementation.”
“While there was a ~60% increase SOD in the present study after 90 days of supplementation, the placebo group had the same increase (Fig 2). However, in a post-hoc analysis in subjects’ >35 years of age, the increase in SOD after three months of supplementation was larger in the Protandim group compared to placebo (Fig 7). Caution is needed for this interpretation, as this subset of analysis was not made a priori. Performing multiple, unplanned, statistical analyses after data is collected is called p-hacking and can be inappropriate [30]. To verify that SOD is improved in older subjects after supplementation with Protandim, another study should be performed addressing that specific question.”
So what we’re are looking at here was a study that was fully completed by the investigators by 2015 and published twice (as a thesis in 2015 and as a research abstract in 2016), reporting nothing but negative results, and then for the full-length journal publication, LifeVantage (the funder) suddenly pops in and insists on including an invalid secondary data analysis that the company conducted, in violation of the pre-specified protocol. All the authors could do in response, apparently, was to include the strong disclaimer that appeared in the article.
I was ready to give credit to Ueberschlag and the other authors for their honesty in including the disclaimer, although they didn’t have much choice given that the study design was pre-registered with ClinicalTrials.gov and that they therefore couldn’t include data analyses outside the protocol without it raising a red flag. That was until I discovered that a portion of the article was plagiarized directly from Wikipedia. Notice that the following paragraph from the article was a virtual cut-and-paste from Wiki.
Text from article (Ueberschlag et al. PLoS One. 2016, page 22):
“In 2012, a double-blinded, randomized, placebo-controlled trial was published that examined the effect of Protandim1 on pulmonary oxidative stress and alveolar permeability in 30 recovering alcoholics [16]. Protandim was supplemented in 14 subjects at a dose of 1350 mg/day (double the daily dose recommended by the manufacturer) or placebo (in 16 subjects) were administered for 7 days. Relative to placebo-treatment, Protandim1 had no significant effects on alveolar epithelial permeability or on TBARS, epithelial growth factor, fibroblast growth factor,
interleukin 1β, and interleukin-10 levels in bronchoalveolar lavage fluid. Treatment with placebo, however, produced a significant reduction in plasma levels of TBARS by ~28% [16].”
http://www.ncbi.nlm.nih.gov/pubmed/27513339
Wikipedia version (overlapping text in all caps for comparison):
“The second study, A DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED TRIAL published by McCord and colleagues IN 2012, EXAMINED THE EFFECT OF PROTANDIM ON PULMONARY OXIDATIVE STRESS AND ALVEOLAR EPITHELIAL PERMEABILITY IN 30 RECOVERING ALCOHOLICS.[31] PROTANDIM (14 SUBJECTS AT A DOSE OF 1350 MG/DAY; DOUBLE THE DAILY DOSE RECOMMENDED BY THE MANUFACTURER) OR PLACEBO (IN 16 SUBJECTS) WERE ADMINISTERED FOR 7 DAYS. RELATIVE TO PLACEBO-TREATMENT, PROTANDIM HAD NO SIGNIFICANT EFFECTS ON ALVEOLAR EPITHELIAL PERMEABILITY OR ON OXIDATIVE STRESS, EPITHELIAL GROWTH FACTOR, FIBROBLAST GROWTH FACTOR, INTERLEUKIN-1Β, AND INTERLEUKIN-10 LEVELS IN BRONCHOALVEOLAR LAVAGE FLUID. TREATMENT WITH PLACEBO, HOWEVER, PRODUCED A SIGNIFICANT REDUCTION IN PLASMA LEVELS OF TBARS, a marker of oxidative stress (i.e., lipid peroxidation).”
https://en.wikipedia.org/wiki/Protandim#Human_clinical_studies
So in summary, we have a company-funded study authored by at least two researchers (the lead author holding only a bachelor’s degree) with a financial conflict of interest (i.e., they were paid by LifeVantage) that was published twice and showed no effects of the product in either instance, but when ultimately published as a full-length article, included a data analysis prohibited by protocol that was foisted on the authors by the company, as well as at least one significant portion of text plagiarized directly from Wikipedia.
In other words, well done LifeVantage! You could not have screwed this up worse.
Vogel says
Sander said: “Why would lifevantage do clinical trials to prove Protandim while its ingredients are proven to have anti oxidant activity?”
That question is incoherent. They fact is that they did do clinical trials; at least 3 that we know of showing that the product was worthless. Is that really so hard for you to admit?
Sander said: “You deny science because of some clinical trials you misinterpret.”
ROFL. That’s one of the most disingenuous things you’ve said to date. I keep thrusting the “science” (for what it’s worth) in your face and you keep trying to look away. It’s hysterical; and it gives everyone the chance to witness first hand the blinding ignorance of Protandim’s shills.
Not only do the studies collectively show that Protandim doesn’t do anything beneficial in humans (thereby failing to live up to ANY of the marketing claims), that latest trial showed high rates of side effects including stomach ache, diarrhea, headache, nausea, dizziness, and low blood sugar. These effects were reported in greater than a quarter of the study population that took the product and at rates more than twice those of the placebo group. Thus, the product is far worse than useless – it offers nothing but harm (metal shard contamination notwithstanding) with zero benefit.
SanderV says
“I keep thrusting the “science” (for what it’s worth) in your face and you keep trying to look away”
Those clinical trials noticed no effect of Protandim in a specific time frame on people with AUD and on runners.
-Alcohol misuse inhibits phagocytic function.
-Exercise creates oxidative stress. If you do a lot of exercise then your body creates more endogenous anti-oxidants, it’s a defense mechanism.
What does it matter that authors did not mention it?
This is proven science.
The properties lifevantage ascribes to Protandim are based on the properties of its ingredients….which are proven beyond any doubt. I’ve posted links before.
You obviously don’t care for science.
Vogel says
Sander said: “Those clinical trials noticed no effect of Protandim in a specific time frame on people with AUD and on runners. Alcohol misuse inhibits phagocytic function. Exercise creates oxidative stress. If you do a lot of exercise then your body creates more endogenous anti-oxidants, it’s a defense mechanism. What does it matter that authors did not mention it?”
Clinging to vague harebrained excuses that you pulled out of a hat won’t get you anywhere. The authors of the studies would have been the first to mention it if they thought that those were even remotely plausible explanations for the product’s failures. They didn’t of course, because they would have been laughed at in peer review.
There is no evidence in the studies of impaired phagocytic function or increased levels of endogenous antioxidants at baseline, nor would this explain why Protandim failed to reduce oxidative stress in 3 studies, contradicting the positive results in the original poorly designed company-run study in 2006.
Even if we were to suspend disbelief and accept your paper thin premise, we’d at least have two populations that we know for certain Protandim doesn’t “work” for – people who run (or do other cardio exercise) and people who drink alcohol regularly. That must represent at least half of their target demographic if not more.
Do you think for one second that Protandim’s marketers will modify their sales pitches based on these results and honestly tell consumers that the product will do nothing for those who exercise or drink regularly? Looking at the brochure LifeVantage put out, one would be led to believe that the runner study was a roaring success, and the company completely ignores the study in recovering alcohol users as though it doesn’t exist.
http://www.lifevantage.com/wp-content/uploads/2016/04/Protandim-and-Runners-Study-Summary-V-06.pdf
Adding injury to insult, the latest trial reported several adverse events associated with Protandim (vomiting, stomach ache, diarrhea, headache, nausea, and dizziness) that occurred in 26% to 32% of the subjects who took the product, and at a rate more than twice that in the placebo group (and a subject in the Protandim group withdrew from the study due to “complaints that it caused her to feel depressed”). Funny how you have now twice stayed silent when confronted with this damning data.
Pretty impossible to justify a product that’s been proven to do nothing other than make a significant number of users feel bad physically. Harder still considering the insultingly inflated price. Harder to the nth degree factoring in the pyramid scheme aspect, chronic lying, impossibly annoying hucksters, parasitism/exploitation, etc.
Sander said: “The properties lifevantage ascribes to Protandim are based on the properties of its ingredients….which are proven beyond any doubt. I’ve posted links before.”
Well, no, pretty much the opposite. Paul Myhill and Bill Driscoll, “invented” and patented the product as a highly specific formulation which was later claimed to have a unique effect differing from that of the individual ingredients themselves (i.e., their “synergism” marketing fairy tale).
Aside from that, whatever the ingredients may or may not have been reported to do individually has no bearing on the fact that Protandim itself has been proven to do nothing several times over. The amounts of ingredients in the product would be far lower than the doses used in any clinical studies that may have reported positive effects with the individual ingredients.
Anyone with basic pharmacological knowledge would understand that, and they would scoff at a premise as flimsy as the one you’re using to try to negate the latest negative results (i.e., insisting that hard clinical trial data on Protandim should be dismissed in favor of unspecified results from unspecified studies on its individual ingredients).
Aside from the glaringly obvious dose issue, maybe the manner in which LifeVantage processes their ingredients causes them to lose biological activity, or maybe they use poor-grade raw material with low amounts of active chemical constituents to start with, or maybe the effects of the individual ingredients cancel each other out when they are combined in proportions according to the Protandim formula: i.e., an exact 3:2:2:1:1 ratio of milk thistle, bacopa, ashwagandha, turmeric, and green tea (225 mg, 150 mg, 150 mg, 75 mg, and 75 mg respectively). There are many possible explanations, but they are all rendered moot when there is hard clinical trial evidence at hand showing that Protandim, regardless of what it may consist of, does nothing and does not live up to any of the marketing claims.
The list of lies and missteps from this organization is voluminous at this point. Your role as their concern is an unenviable one to be sure. Threading that fine line of ineptly pretending to understand science while being selectively blind to every bit of damning scientific evidence is a difficult tightrope act.
SanderV says
“Clinging to vague harebrained excuses that you pulled out of a hat won’t get you anywhere.”
That was proven science.
MICHAEL says
I AM A CLINICAL RESEARCHER AND HAVE CONDUCTED AND DOCUMENTED MANY PEER REVIEWED STUDYS AND THE MISSING VILLIAN HERE IS THE FDA. ANYTHING THAT MAY HAVE A CHANCE AT REPLACING PHARMACOLOGICAL PROTOCOLS IS A SERIOUS THREAT TO ONE OF THE LARGEST LOBBIES IN THE WORLD.
AND FURTHERMORE I TOOK PROTANDIM FOR 3 YEARS AND STILL DO. I HAVE ( HAD) SEVERE OSTEOARTHRITIS AND PROTANDIM IS THE ONLY REGIMEN THAT ACTUALLY REDUCED THE CHRONIC INFLAMMATION. MY DOCTORS HAD WRITTEN ME OFF AS A DUAL KNEE REPLACEMENT CANDIDATE THEN AFTER A FEW WEEKS ON PROTANDIM THEY CAN’T BELIEVE THAT NOW I WALK AND RUN AND EXERCISE HIKE, SURF,.
I AM 61 YEARS OLD AND THIS HAS GIVEN ME A NEW LEASE ON LIFE. i ALSO TOOK THE T-BAR TEST BEFORE AND AFTER STARTING THE REGIMEN AND MY T-BARS WERE REDUCED 38% IN 8 WEEKS. TO TOP IT OFF I WAS COMPLETELY BALD ON THE CROWN OF MY HEAD AND NOW HAVE A FULL HEAD OF HAIR WITHOUT USING ANYTHING ELSE.
I HAVE WORKED WITH SOME OF THE MOST CREDIBLE MEDICAL AND GENETIC RESEARCHERS IN THE WORLD AND THERE IS A MOUNTAIN OF EVIDENCE AND MORE PEER REVIEWED CLINICAL TRIALS GOING ON EVERYWHERE THAT SHOW SIGNIFICANT EVIDENCE THAT PROTANDIM DOES APPEAR TO UPREGULATE DNA AND TELEMERE REPAIR ALLOWING MORE NATURAL PRODUCTION OF SOD AND OTHER NATURALLY OCCURRING ENZYMES THAT HAVE BEEN DEPLETED WITH AGE.
I WOULDN’T GO A DAY WITHOUT IT. I HAVE GIVEN IT TO DOUBTERS WHO ARE NOW REGULAR CONSUMERS. YOU SEE THERE ARE OTHER FACTORS IN JUDGING CLINICAL RESULTS. ONE OF THEM IS THE HUMAN RESULT. THE FDA HAS BEEN MAKING A FORTUNE DEGRADING SCIENCE AND PROGRESS ON COUNTLESS PROTOCOLS IN ORDER TO PRESERVE THE PROFITS THEIR SHAREHOLDERS REFUSE TO LET GO OF.
AS WAS MENTIONED ALREADY IN VIVO STUDIES ARE DIFFERENT, MAINLY BECAUSE THEY HIDE THE UNSEEN PATHWAYS OF PERIPHERAL BENEFITS TO THE ORGANISM AS A WHOLE. AND AS FAR AS THERE BEING RECENT FOLLOW UP STUDIES ON THIS PRODUCT AND NRF2 PATHWAYS SOMEONE MUST BE LIVING IN A VACANCY. THEY ARE EVERYWHERE. LIKE EVERYTHING ELSE HOWEVER OUR INDIVIDUAL GENES DO NOT ALWAYS METABOLIZE THE COMPONENTS IN THE NRF2 PATHWAY IN THE SAME WAY OR EXPRESS IN THE SAME VOLUMES.
SO THE EFFECTS ARE NOT ALWAYS OUTWARDLY APPARENT OR DETECTABLE. BUT FOR THE MAJORITY OF PEOPLE THAT TAKE PROTANDIM ON A REGULAR BASIS THEIR LIVES HAVE BEEN CHANGED. THAT IS AN ENTIRELY DIFFERENT STUDY THAT CANT BE REPRODUCED IN A LABORATORY. AFTER YEARS OF DOING THIS YOU EVENTUALLY FIND THAT THE MOTIVATION OF MANY CLINICAL TRIALS IS TO STOP THE COMPETITION AND PRESERVE A PROFIT MARGIN THAT DOESN’T BRING SCIENTIFIC PROGRESS OR HELP HUMANITY OR EVEN SEEK THE TRUTH. I HAVE SEEN THE END RESULT AND SO HAVE MANY OTHERS. THAT’S THE PART OF SCIENCE THAT IS IN MOTION AND ALIVE LIKE THE ORGANISM ITSELF.
THERE ARE SOME THINGS YOU CANT MEASURE WITH CONTROLLED STUDIES. REAL LIVING BEINGS ARE MORE COMPLEX THAN THAT. TRY IT. IF IT DOESN’T WORK FOR YOU THAN I REALLY FEEL SORRY FOR YOU. YOU ARE REALLY MISSING OUT ON ONE OF THE ONLY ANTI-AGING REGIMENS THAT ACTUALLY WORKS
Vogel says
There is now a total of 3 studies in humans which show that taking Protandim does not significantly reduce oxidative stress. The first study to demonstrate the lack of effect of Protandim on TBARS, a randomized blinded placebo controlled trial, was published in 2012 by Burnham et al.
http://www.ncbi.nlm.nih.gov/pubmed/22268125
In that study, subjects were given a double dose of Protandim for 7 days and it did absolutely nothing even though 7 days is within the time-frame for near-maximal effect on TBARS, according to the results of the 2006 LifeVantage-funded study published by Nelson et al. (a poor quality non-randomized, non-controlled, non-blinded study), which stated:
‘Fig. 3 shows that the response of plasma TBARS is fairly rapid, with most of the change having occurred by 5 to 12 days.’
http://www.livelongerandprosper.com/resources/cs_2006_protandim.pdf
The second study to demonstrate the lack of effect of Protandim was an abstract published in FASEB J in 2014 by Scalzo et al. (incidentally, abstracts are not considered reliable because they do not report full results or methodology and do not undergo proper per review).
The abstract reported that two formulations of Protandim were studied: one lacking ashwaganda and one with piperine substituted for ashwaganda (the version allegedly sold in Japan because ashwaganda is banned). The first formulation actually increased TBARS, and in the group that took the second formulation, TBARS at the conclusion of the study were higher (4.9 nM) than in the control group (4.7 nM) at baseline (i.e., before taking anything).
http://www.fasebj.org/content/28/1_Supplement/LB399.short
The third study (by Ueberschlag et al.), which was just published, was a randomized, placebo-controlled, blinded trial, and the primary data analysis showed that Protandim had no significant effect on TBARS or any other parameter measured.
“Running performance was not altered by Protandim® or placebo [20.3 (2.1) minutes, with an -8 (33) seconds change in 5-km time regardless of group]. There was no change in TBARS, SOD, or GPX (at rest) after three months of Protandim supplementation compared to placebo.”
Incidentally, this study’s lead author (Seteena Ueberschlag) held only a bachelor’s degree in Phys Ed at the time and was funded by LifeVantage; and the article was published in the one of the worst journals imaginable – PLosS One – a pay-to-publish open-access dumping ground for studies that can’t get published elsewhere.
http://www.ncbi.nlm.nih.gov/pubmed/27513339
It’s interesting that this paper reported the last minute inclusion of data from a sub-analysis of TBARS by subject age that was not specified in the study protocol, which is a no-no – a cheat known by scientists as “p hacking”. The authors included a very unusual disclaimer about LifeVantage ramming this new data down their throats for inclusion in the paper:
“LifeVantage had no role in study design or data collection. They did, however, have access to the de-identified raw data of which an independent statistician hired by them verified our analyses. In a sub-analysis that their statistician performed, they showed that SOD increased in subjects equal to and greater than 35 years of age. While age related changes in SOD with supplementation was not made a priori, we added the results to the manuscript and discuss the ramifications of performing unplanned statistical tests in the manuscript.”
They also included verbiage admitting that the post-hoc TBARS analysis by age was invalid:
“Caution is needed for this interpretation, as this subset of analysis was not made a priori. Performing multiple, unplanned, statistical analyses after data is collected is called p-hacking and can be inappropriate [30]. To verify that SOD is improved in older subjects after supplementation with Protandim1, another study should be performed addressing that specific question.”
It’s not only clear that it was inappropriate for LifeVantage to have thrust this data on the authors for last minute inclusion in the article, there is actually a paper trail of earlier reports on this study confirming that Protandim had no effect. First, the lead author of the study (the bachelor’s student funded by LifeVantage) published the entirety of this work in a thesis in 2015 – it showed definitively that Protandim had no effect. Similarly, a research abstract of the same study published in 2016 reported that Protandim had no effect.
http://ir.library.louisville.edu/cgi/viewcontent.cgi?article=3262&context=etd
http://www.fasebj.org/content/30/1_Supplement/898.5?cited-by=yes&legid=fasebj;30/1_Supplement/898.5
It’s clear that LifeVantage made a last ditch effort to polish this turd of a study but they failed in epic fashion. All they did was prove to the world how far they are willing to go to disseminate pseudoscience.
What’s even worse is that the latest study presented a data table showing that subjects taking Protandim had much higher rates of adverse events as compared to the placebo group (e.g., with respect to stomach ache, headache, constipation, nausea, dizziness, and low blood sugar). In fact, the total number of subjects reporting various adverse events was almost twice as high in the Protandim group (40) vs the control group (21). Amazingly, the authors failed to address the adverse events rates at all in the discussion section of the article – a glaring error of omission.
Conclusion: Protandim does nothing except to cause adverse events and suck consumers dry financially.
SanderV says
“Conclusion: Protandim does nothing except to cause adverse events and suck consumers dry financially.”
Then how do you explain that the anti-oxidant activity of Protandim’s ingredients has been proven beyond any doubt? (in clinical trials)
And what about all those people (and dogs) which have beneficial effects from using Protandim?
You know that alcohol misuse inhibits phagocytic function which explains why they did not find any reduction in TBARS…in 7 days.
But you present that trial as being evidence anyway.
People that sport (especially young people) have a higher level of SOD and glutathione to deal with the increase in oxidative stress….which explains the results of the new trial.
Doing clinical trials with Protandim is pointless. It does not give any scientific knowledge since you can’t know which ingredients is responsible for whatever effect is noticed.
Those clinical trials are only interesting for lifevantage.
And if you do test the effect of Protandim you should test it on people with a neuromuscular disease or elderly…people with a know oxidative stress-problem.
Vogel says
Sander said: “Then how do you explain that the anti-oxidant activity of Protandim’s ingredients has been proven beyond any doubt? (in clinical trials)”
I have no idea which clinical trials about individual ingredients you are referring to, but regardless, the question is irrelevant. The overarching point here is that the clinical trials to date show that Protandim doesn’t “work”. No further explanation is needed.
Sander said: “And what about all those people (and dogs) which have beneficial effects from using Protandim?”
All those people??? Which people? And which dogs? There have been no published studies in dogs showing any beneficial effects, and the studies in humans show that it does nothing. You must be referring to a few distributors who would say anything to make a buck and who anonymously post fanciful yarns on blogs and YouTube. That’s not at all hard to explain, especially in light of the organization’s track record.
Sander said: “You know that alcohol misuse inhibits phagocytic function which explains why they did not find any reduction in TBARS…in 7 days.”
Watching you flail about trying to dismiss the failure of Protandim in the 2012 clinical trial (Burnham et al.) is most amusing. The study mentioned nothing whatsoever about alterations in phagocytic function and the authors did not offer that as an explanation for the product’s failure to do anything in the trial. Nor would it explain the failure of Protandim to do anything in the latest 2016 trial in healthy runners (Ueberschlag et al.), which yet again proved that the product is worthless.
http://www.ncbi.nlm.nih.gov/pubmed/22268125
http://www.ncbi.nlm.nih.gov/pubmed/27513339
Sander said: “But you present that trial as being evidence anyway.”
Right, because it is evidence. The fact that you lamely assert otherwise is not only irrelevant, it demonstrates how far you’re willing to bend over backwards to mislead people. Even the authors of the latest 2016 trial ((Ueberschlag et al.) discussed Protandim’s failure in the 2012 trial (Burnham et al.) to which you are referring. You seem to be the only person who still doesn’t get it.
Sander said: “People that sport (especially young people) have a higher level of SOD and glutathione to deal with the increase in oxidative stress….which explains the results of the new trial.”
“People that sport”??? What is that supposed to mean? Regardless, the authors of the study (Ueberschlag et al.) said nothing of the kind.
Sander said: “Doing clinical trials with Protandim is pointless. It does not give any scientific knowledge since you can’t know which ingredients is responsible for whatever effect is noticed.”
Perhaps you should posit that to LifeVantage and ask to stop conducting in vitro and animal studies and using them for marketing because, by your reasoning, they are even more worthless.
The human trials to date have value in that they conclusively demonstrate that the product is worthless and does not come anywhere close to living up to any of the marketing claims. You would have been totally fine with these trials if they gave any results that you could have used to assist your efforts to sell this worthless crap.
Sander said: “Those clinical trials are only interesting for lifevantage.”
What an extremely odd thing to say. I found it very interesting that the trials conclusively demonstrate the product to be worthless, which confirms what intuition, logic, and strong circumstantial evidence has told us all along.
Sander said: “And if you do test the effect of Protandim you should test it on people with a neuromuscular disease or elderly…people with a know oxidative stress-problem.”
You’d think that would have dawned on LifeVantage in the last decade, which they instead spent dithering around, financing worthless test tube and animal studies as marketing fodder. They could have easily submitted a new investigative drug application to the FDA by now requesting authorization to test the product on people with diseases.
What is certain at this point is that any further studies of the product would be pointless in light of the clinical trial failures to date. By the looks of things though, LifeVantage may not be around long enough to finance any more studies anyway. Good riddance!
http://seekingalpha.com/article/4003257-lifevantage-mlm-opportunity-top-1-percent-can-collect-food-stamps
SanderV says
Why would lifevantage do clinical trials to prove Protandim while its ingredients are proven to have anti oxidant activity?
I posted it before.
And it’s not just one clinical trial….there are many.
You deny science because of some clinical trials you misinterpret.
LisaRob says
SanderV says: “Why would lifevantage do clinical trials to prove Protandim while its ingredients are proven to have anti oxidant activity?”
Why? Because Lifevantage does not sell the individual ingredients to consumers. They are the ones creating a pill, charging a premium for it, and claiming that their formula is exceptional in some way. Then, they encourage their distributors to make all kinds of ridiculous health claims based on this super special patented formula.
Lifevantage claims it is a “science based” company and everything they do is backed by science. They have the burden of proof, and they are failing spectacularly at it. At this point, they would be better off NOT doing any more human studies…LOL.
Vogel says
Sander said: “What you explain happens when you take an excess of anti-oxidants.”
There is no recognized definition for taking “an excess of anti-oxidants”. Your comment is meaningless. The concern is with taking antioxidant supplements, period. Not “excess”.
Sander said: “Some antioxidants can reduce metal ions that generate free radicals through the Fenton reaction. So they act as pro-oxidants. One example is vitamin C and iron. Excess antioxidants also mitigate free radicals that are needed for normal cellular functions, such as killing germs.”
Actually, the Fenton reaction is non-physiological. What you are referring to is known by biochemists formally as the Haber-Weiss reaction. Hydroxyl radicals generated in this manner can be toxic, but that’s only one mechanism by which antioxidants (like vit C) can promote cancer, and it was obviously not the mechanism I was referring to when I specifically mentioned the disruption of cell signaling and apoptotic pathways.
Furthermore, the antimicrobial effects of free radicals that you mentioned have nothing to do with cancer chemotherapy. In your case, a little knowledge (emphasis on “little”) is a dangerous thing.
Sander said: “And yes, chemotherapy destroys cells with free radicals. Anti-oxidants should reduce the damage done by chemo.”
You are missing the point, which was that antioxidants can disrupt the tumoricidal effects of chemo/radiotherapy and in so doing protect cancer cells from destruction, thereby promoting cancer.
Thus, taking antioxidants during cancer therapy is contraindicated. On the other hand, taking the idiotic supplement you’re promoting is unjustifiable under any circumstance.
SanderV says
“There is no recognized definition for taking “an excess of anti-oxidants”. Your comment is meaningless.”
Yes there is, it just needs to be tested.
Reservatrol for example works as anti-oxidant or pro-oxidant and anti-apoptotic or pro-apoptotic…depending on the dose.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2990065/
It’s a very big and complex part of science.
You can always cherry-pick to find non-existing evidence.
If you have any understanding of evolution then you should know that the presence of anti-oxidants in many plants is proof for the positive effects.
Vogel says
Yes another epic fail for Protandim.
http://www.ncbi.nlm.nih.gov/pubmed/27513339
LisaRob says
It isn’t my logic, I am not a scientist. Here is just one source:
http://www.medscape.com/viewarticle/828132#vp_2
“This issue of antioxidants being harmful to cancer patients was raised last year by Nobel laureate James Watson, PhD, who is chancellor emeritus at the Cold Spring Harbor Laboratory. He described a new hypothesis on reactive oxygen species that he considers is “among my most important work since the double helix.”
Dr. Watson proposed that antioxidant levels within cancer cells are a problem and are responsible for resistance to treatment, and that the untreatability of late-stage cancer might be the result of “its possession of too many antioxidants.”
“The time has come to seriously ask whether antioxidant use more likely causes than prevents cancer,” Dr. Watson said. Nutritional intervention trials have shown no obvious effectiveness in preventing cancer or in lengthening mortality, and, “in fact, they seem to slightly shorten the lives of those who take them.”
Dr. Tuveson, who works at the same institution, commented at the end of the interview that “Dr. Watson is usually a few steps ahead of the rest of us.”
Debb Kapp says
I’d like to add my caution for ordering Lifevantage products from Amazon. There have been cases where the product received was not Protandim and not even the correct form for the product and other cases where the product was outdated or appeared to have been improperly stored. Aside from that Why wouldn’t you want to support a distributor? Yes, i am one. We pay the same price for product as our customers, there is no price gouging. I have chosen to in essence operate a franchise. The job market in my region is very poor and network marketing provides an opportunity for me.
As for the products, yes I am totally enamored. I use everything except the Canine Health. I took Protandim for almost a year before becoming a distributor. I “felt” that I was benefiting from use early on. At about the one year mark my blood work showed marked improvement.
I’m glad I did not wait for iron-clad proof before trying Protandim. I look at the scientific validation as promising but my experience and blood work are proof enough for me. After all, no one, to my knowledge, has indicated that there is potential harm (except the Lifevantage company warnings about chemotherapy and pregnancy ) in trying the product out for yourself. My own Doctor simply said ” Well it won’t hurt you” when I first showed it to him.
Now he is cautiously optimistic about me actually being able to eliminate medications after reducing my blood pressure meds doses twice. It is not a magic bullet, it takes time to have an impact, it simply turns on our own bodily process so individuals will naturally have differences in response, but don’t dismiss the possibilities for lack of 100% totally indisputable proof.
LisaRob says
Distributors love to circulate rumors of “fake” Protandim being sold on Ebay or Amazon. There is no reason to believe that fake Protandim is being sold. Why would anyone bother to fake something that is not in high demand? It’s not like Protandim is a designer purse or other highly sought after product. The product being sold on Amazon or Ebay is extra product accumulated by distributors as they try to maintain their position in the pyramid.
As a distributor, it is illegal for you to imply that Protandim has done anything but lower your oxidative stress. I doubt that is really legal either, since there is not enough scientific evidence to support that claim. Unfortunately, the FDA and FTC haven’t turned their attention to this product/company, yet. They have bigger fish to fry.
As to whether the product can harm you or not….who knows? Some of the ingredients can interfere with medications, and lowering oxidative stress (if it does that) could allow cancer cells to grow. There hasn’t been enough study, either way.
Why use an unproven product from a sketchy company? Even the inventor of Protandim, Paul Myhill, no longer takes the product. He’s moved on to other things.
Quattro Dosanto says
Lowering the stress on your body could allow cancer cells to grow? I would love to hear your logic on that one.
Vogel says
Quattro Dosanto said: “Lowering the stress on your body could allow cancer cells to grow? I would love to hear your logic on that one.”
Could do without the sarcasm, but whatever. What Lisa said is widely recognized in free radical biochemistry. Oxidative reactions are a double-edged sword because on the one hand, they can contribute to inflammation and carcinogenesis; on the other, free radical signalling pathways play an important role in the apoptotic cascade that leads to the tagging and destruction of neoplastic cells (i.e., an anticancer effect).
Aside from that, oxidative reactions are one of the mechanisms by which various anticancer drugs destroy cancer cells. Inhibiting those reactions through supplementation with antioxidants can interfere with the therapeutic effects of those drugs and thereby promote cancer growth.
SanderV says
What you explain happens when you take an excess of anti-oxidants.
Some antioxidants can reduce metal ions that generate free radicals through the Fenton reaction. So they act as pro-oxidants.
One example is vitamin C and iron. Excess antioxidants also mitigate free radicals that are needed for normal cellular functions, such as killing germs.
Everything is ‘poisonous’ when you take in an excess..including water.
And yes, chemotherapy destroys cells with free radicals.
Anti-oxidants should reduce the damage done by chemo.
This has never been proven though.
http://www.ncbi.nlm.nih.gov/pubmed/17283738
With anti-oxidants you can protect healthy cells from chemotherapy…
There might be a way to increase the dose of chemotherapy while decreasing the damage done on healthy cells….with anti-oxidants.
SanderV says
I know the meaning of the word pluripotent, that’s why I placed it between ”.
“there is no reason to assume that the subjects in the 2006 study were any healthier than those in the 2012 study.
”
Stop interpreting everything to fit your beliefs. The people in the 2012 study had AUD….they were not healthy, they were sick.
If you google it, then you’ll see there is a connection between alcohol misuse and phagocyte inhibition.
http://www.ncbi.nlm.nih.gov/pubmed/3985669
http://pubs.niaaa.nih.gov/publications/arh40/97-108.htm
“Protandim was shown in the best designed clinical trial to date to do nothing – absolutely NOTHING! ”
What’s wrong with your mind?
Vogel says
Sander V said: “The people in the 2012 study had AUD….they were not healthy, they were sick.”
They were not sick. They were simply alcohol drinkers — i.e., subjects with “alcohol use disorder” (AUD) — but otherwise healthy. This is stated explicitly in the introduction of the paper:
“We conducted a randomized, double-blinded, placebo-controlled trial to determine the effects of 7 days of directly observed oral Protandim therapy on measures of intrapulmonary oxidative stress among OTHERWISE HEALTHY SUBJECTS with a history of AUDs”
http://ajplung.physiology.org/content/302/7/L688
The subjects in the 2006 study were not screened for baseline health status or alcohol consumption, so there is no reason to presume that the subjects in that they were any healthier than the subjects in the 2012 study — i.e., the randomized placebo-controlled clinical trial that showed Protandim had no significant effects on any oxidative stress or health-related parameter assessed.
http://www.ncbi.nlm.nih.gov/pubmed/16413416
Don’t you ever tire of being wrong?
SanderV says
This is what is said in the 2012 study:
“Alcohol use disorders (AUDs), including alcohol abuse and dependence”
When you just drink alcohol, you don’t have an AUD.
They are otherwise healthy which means AUD is there only disease.
It’s known that alcohol inhibits phagocytic function. This debunks you and the 2012 study.
Rick says
The study is incomplete. It was SEVEN day study. Not enough time for the body to produce the enzymes and then allow the body to respond and begin to heal. This study needs to be addressed again with a longer time period, maybe 2-3 months.
That is the equivalent of producing a study where everyone was obese and was addicted to food (instead of alcohol) and having them exercise for seven days. At the end of the seven days, weight them, re-run their blood work and see no change and concluding that exercise is in-effective for weight loss, and in fact has no noted benefits. It’s a ridiculous study.
Vogel says
Rick said: “The study is incomplete. It was SEVEN day study. Not enough time for the body to produce the enzymes and then allow the body to respond and begin to heal. This study needs to be addressed again with a longer time period, maybe 2-3 months.”
(1) It is rather arbitrary and not technically accurate to label this study as “incomplete”. One could conceivably argue that it would have been interesting had the experiment been of longer duration, but “incomplete” is simply not an accurate term to describe it. If it was deemed incomplete by the scientific peers that reviewed the article prior to publication, it wouldn’t have been published.
(2) “Healing” was not one of the parameters examined in the study.
(3) The 2006 study by Nelson et al. reported that TBARS were decreased SOD induction was near maximal after 7 days of treatment with Protandim at a dose of 338 mg/day, which is one quarter of the dose used in the 2012 study. Thus, the 7-day time-frame should have been more than sufficient to observe an effect of the product on TBARS. However, TBARS levels (an oxidative stress marker) were reduced only in the placebo group. Protandim had no effect on any other oxidative stress parameters measured, which is consistent with the results of the primary data analysis in the 2016 runner study.
Rick said: “That is the equivalent of producing a study where everyone was obese and was addicted to food (instead of alcohol) and having them exercise for seven days. At the end of the seven days, weight them, re-run their blood work and see no change and concluding that exercise is in-effective for weight loss, and in fact has no noted benefits. It’s a ridiculous study.”
No, it’s not even remotely analogous to that paradigm. Seven days would have been quite sufficient for a reduction in TBARS to occur. The problem isn’t the time-frame; it’s that the product doesn’t do anything in people when it’s assessed using stringent experimental design (i.e., randomization, blinding, and placebo control).
Greg B says
“Also, doing clinical trials with Protandim is pointless. Clinical trials should be done on its ingredients separately.’
What a stupid comment! Protandim is a patented formula, meaning there are certain amounts of each ingredient in it, and it is this combination that has the effect, which has been shown in tests to be much greater than the combined effects of the ingredients by themselves. That is, this combination has a multiplier effect, not a mere addition effect.
Besides, clinical trials should be conducted on all such products; it’s the best way to determine how well they work.
SanderV says
“and it is this combination that has the effect, which has been shown in tests to be much greater than the combined effects of the ingredients by themselves”
Can you show those tests?
Vogel says
Sander V said: “Is it so hard to understand that oxidative damage doesn’t just disappear when you remove oxidative stress? TBARS is a byproduct of lipid peroxidation, it doesn’t disappear when you remove oxidative stress. Removing of oxidative stress prevents new TBARS to be formed.”
It’s really not complicated at all. LifeVantage bases their marketing claims about reducing oxidative stress on the TBARS results from the 2006 study by Nelson et al. (a non-randomized, non-controlled, non-blinded study authored by the company’s employees).
http://www.ncbi.nlm.nih.gov/pubmed/16413416
However, the TBARS results from the more recent and better designed study (a randomized, double-blind, placebo controlled study) showed that Protandim had no effect on TBARS, and at a dose double that recommended by the manufacturer and double the dose used in the 2006 study. In other words, the company’s marketing claims do not hold up to scrutiny.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330762/
Sander V said: “There is only one way to measure oxidative stress and that’s by measuring ROS.”
That statement reveals how little you know about ROS biochemistry (or even the definition of the term oxidative stress). Almost all ROS are short-lived and highly reactive molecules, which means that they typically are not measured directly but rather using a proxy measure (a footprint) based on the reaction of ROS with other molecules. In addition, LifeVantage has not attempted any direct measurements of ROS production in people who take the product, yet they nonetheless claim that the product lowers oxidative stress. Those claims are obviously baseless.
Sander V said: “All ingredients in Protandim have been proven to have positive effects…in clinical trials.”
There’s no point arguing about what the individual ingredients in Protandim may or may not have been reported to do in isolation (putting aside the issue of comparative doses). Protandim is not equivalent to its individual ingredients in isolation, and a clinical trial has proven that Protandim does virtually nothing.
SanderV says
You don’t understand anything!
The study were they did not notice a lowering in TBARS lasted only 7 days.
In the one that lasted 30 days they saw a reduction in TBARS.
7 days 30days…………..see the difference?
TBARS is a byproduct of oxidative damage…it takes time for it to reduce in %.
And yes, ROS have short half lifes.
That means you measure oxidative damage and you have to correctly interpret the study…but that’s impossible for you apparently.
So you claim the anti-oxidant activity of the separate ingredients doesn’t prove the anti-oxidant activity of Protandim????
What’s wrong with you?
Vogel says
Sander V said: “You don’t understand anything! The study were they did not notice a lowering in TBARS lasted only 7 days. In the one that lasted 30 days they saw a reduction in TBARS. 7 days 30days…………..see the difference? TBARS is a byproduct of oxidative damage…it takes time for it to reduce in %.”
ROFL! Greg was trying to float that same hopelessly flawed excuse here a while back until it was handily shot down.
http://supplementclarity.com/protandim-research-review-lifevantage/comment-page-16/#comment-86834
I’ll repost the gist of what I wrote in the summer of 2014 in response to Greg’s baseless claim:
“The angle that the LifeVantage/distributors seem to be using to discount the 2012 clinical study is that it wasn’t long enough in duration (i.e., only 7 days). But…McCord himself stated in the 2006 paper that the peak effect of Protandim on TBARS/oxidative stress occurs in 5-12 days. The article stated (p345):
‘Fig. 3 shows that the response of plasma TBARS is fairly rapid, with most of the change having occurred by 5 to 12 days.’
http://www.livelongerandprosper.com/resources/cs_2006_protandim.pdf
So, clearly, the fact that the 2012 study was 7-days in duration does not qualify it as incomplete. The timeframe selected for the study seems to have been perfectly reasonable. But let’s pretend for the sake of argument that it wasn’t.
McCord/LifeVantage were involved in virtually aspect of this study, so if the 7-day timeframe was too short, why did they allow the study to proceed when they would have know a priori that it was “incomplete”. To have done so would have demonstrated incompetence; it would have been an abuse of the subjects who participated in the study; and it would have been a colossal waste of money, which they would not be able to defend to shareholders.”
In other words, according to the 2006 research that LifeVantage/McCord published, the effect of Protandim on plasma TBARS should have already been near maximal by day 5 and yet no effect was seen on TBARS (or anything else) at day 7 in the 2012 human clinical trial. Another bust for LifeVantage; and yet another failed attempt to rationalize away the facts with shallow, hastily formulated, reflexive BS.
Sander V said: “So you claim the anti-oxidant activity of the separate ingredients doesn’t prove the anti-oxidant activity of Protandim???? What’s wrong with you?”
I am saying that the 2102 study showing that Protandim didn’t have antioxidant activity in people who took the product supersedes any and all other research on what the individual ingredients may or may not do when studied separately and at doses that aren’t necessarily the same as those in Protandim. It’s not complicated.
SanderV says
You are comparing TBARS in the plasma of healthy people (between 20 and 78)with TBARS in BAL of people with alcohol misuse?
Do you honestly think that makes any sense?
I suppose TBARS is cleaned up by phagocytes…there are many things which can accelerate or inhibit this process.
If you combine ingredients with a different anti-oxidant activity then you create something with ‘pluripotent’ anti-oxidant activity.
There are countless supplements which consist of several ingredients.
Vogel says
Sander V said: “You are comparing TBARS in the plasma of healthy people (between 20 and 78) with TBARS in BAL of people with alcohol misuse? Do you honestly think that makes any sense?
Perfect sense. The subjects in the 2006 clinical study didn’t go through any health screening, according to the enrollment procedures described in the methods section, and prospective participants in the 2012 study were excluded if they had any diseases. Furthermore, the 2006 study included subjects as old as 78 years while the average age of the subjects in the 2012 study was about 45 years. In other words, there is no reason to assume that the subjects in the 2006 study were any healthier than those in the 2012 study.
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.486.5717&rep=rep1&type=pdf
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330762/
Additionally, the serum TBARS levels at baseline in the 2006 study ranged from about 1 uM to 3.5 uM and in the 2012 study, the average levels at baseline ranged from 2.0 – 2.5 uM. Collectively, these data show the lack of a difference in baseline oxidative stress levels between the subject cohorts in the two studies.
In other words, you are grasping at straws yet again – one more in a series of blind reflexive attempts to defend Protandim with no regard whatsoever for the research data, logic, and basic commonsense.
Sander V said: “If you combine ingredients with a different anti-oxidant activity then you create something with ‘pluripotent’ anti-oxidant activity.”
Ha! You sound like a random word generator, and you obviously don’t know the meaning of the word pluripotent. These bizarre abstractions serve no purpose. Protandim was shown in the best designed clinical trial to date to do nothing – absolutely NOTHING!
Sander V said: “There are countless supplements which consist of several ingredients.”
That was a witless statement utterly devoid of insight – white noise — as usual.
Dr. Hesu Whitten DC says
Vogel if you were not wanting to debate vaccination you would have simply said that is not a subject I wish to discuss. But you’re bright enough to realize your assertions about the efficacy of vaccines, the deficiencies of chiropractors’ education, and that Mercola is a fear-mongerer beg a response.
Your belief seems to be that if a medical drug (such as vaccination) or procedure is in practice it must have scientific validity. To poke a hole in your bubble take a look at Irving Kirsch’s talk on his review of the raw data, which he acquired from the FDA, on the effects of Anti-depressants compared to placebo.
http://tinyurl.com/jgrn59g
His work was so thorough he was invited to speak on 60 Minutes a few years back. He essentially proved that anti-depressants work no better than placebo (except in the most extreme cases) and that depression has little to nothing to do with Serotonin. Once you embrace these facts you start to question whether all the other multi-billion dollar medical markets have any scientific basis. The cancer researchers have been so sure (for the past 45 years) that once the genome technology was sufficiently advanced they could simply identify which genes were causing a particular type of cancer and create drugs to target those genes.
When the day came to decode tumors and mutations they discovered there are no genetic patterns. Two people with the same cancer have wildly different mutations so there is no gene to target! So after all this time (and money) they are eating humble pie and realizing cancer is a metabolic disease as Otto Warburg knew 100 years ago. It’s about damaged mitochondria and the cell’s converting from aerobic metabolism to fermentation. (See “Tripping Over the Truth”)
As far as fear mongering…there is a lot to be afraid of in the health of Americans. We are the most obese nation on earth, thanks in large part to the crap that is permitted to be sold as “food” in this country. We have some of the poorest health outcomes among the industrialized nations, despite spending many times more money on health care. Time magazine reports 100 million Americans are in chronic pain and we have an Opioid epidemic. Something like 40% of people will get cancer in their lifetimes and the cancer industry is still looking for a miracle gene. If this isn’t cause for concern I don’t know what is. You have to admit something is not right.
And I do live in California so when a failed medical system forces its autism shots on my child I get very concerned. And you say you’re glad that they do because an unvaccinated child poses a risk to other children. Well think this through, genius. If your child is vaccinated he is supposedly “immunized”. How is my unvaccinated child a risk to your child. He’s supposedly protected by the vaccination, no? And once we give the government the right to impose its programs on children against the parents’ will we have essentially slipped into a totalitarian state.
If the government wants to force such a campaign on children they need to have studies which show an overwhelmingly convincing benefit:risk ratio that was performed by independent parties. If those studies exist they should be presenting them on the news, in schools etc. But the truth is it’s just big Pharma controlling the FDA and influencing legislation for profit.
As for my chiropractic education, it’s the real deal. I stunk from cadaver lab for an entire year. I studied pathology, biology, 8 trimesters of xray, biochem, pharmacology, nutrition etc. etc. I was going to send you my list of courses because I’m sure you have no idea but I have nothing to prove to anyone.
I love that we live in a country where we can debate like this. I like how you are able to decipher research studies. It is tedious and I was hoping to find an ally in my quest to challenge the vaccination studies but I will clearly need to keep looking.
Vogel says
Hesu Whiten DC said: “Vogel if you were not wanting to debate vaccination you would have simply said that is not a subject I wish to discuss.”
You mean like when I unambiguously said the following…
“Now why would you go and do a thing like that after getting off to such a nice start? Rule 1 is don’t derail discussions with off-topic subjects.”
…or the half dozen times I reiterated to you that the subject is off-topic and has no place here?
I skimmed through the rest of your latest comment and noticed that it didn’t contain a single word about Protandim. You can continue your off-topic soap-boxing soliloquies if you wish, assuming the blog host continues to tolerate these disruptive hijacking attempts, but I can’t imagine why anyone would be that tone deaf and antisocial.
Hesu Whitten DC says
Oh now you’ve gone and done it Vogel! And if I forget to later, thank you for taking my challenge to address the vaccination debate. Btw, what is your educational background? Or do you prefer to keep that secret?
And since this chat is about education I’ll have you know chiropractors have as many classroom hours as MD’s and take the same basic sciences.
As for Dr. Humphries, nephrologist, she is fully qualified to write this book as her curiosity was piqued after seeing several kidney failure cases shortly following flu vaccination. Her analysis of the mortality data spanning 150 years in Europe and the US didn’t require a degree in virology of immunology. Small pox, for example, was pretty much gone around 1920s but the vaccine came out in 1797. Despite scaremongering tactics to vaccinate the great majority in Europe the vaccine had no effect on mortality.
The hero was sanitation, chlorination water, and improved hygiene. Vaccination has not eradicated a single epidemic. And Dr. Humphries has nothing to gain by publishing her findings. A few book sales maybe? On the contrary she risks professional ridicule as many who have questioned the established dogma.
And you Vogel…You’re now an expert on this too? If you read this one book, or even just the chapter on Polio, I’ll shut up and let you continue to be the know-it-all that you are (even though you probably are right most of the time). I’ll get back to you about autism. A few things I want to research.
Vogel says
Hesu Whitten DC said “Oh now you’ve gone and done it Vogel! And if I forget to later, thank you for taking my challenge to address the vaccination debate.”
I didn’t. I said that this isn’t the place to debate vaccinations because vaccinations have nothing to do with the topic of Protandim.
Hesu Whitten DC said: “Btw, what is your educational background? Or do you prefer to keep that secret?”
Also off topic.
Hesu Whitten DC said: “And since this chat is about education…”
It’s not. It’s a discussion about Protandim
Hesu Whitten DC said: “I’ll have you know chiropractors have as many classroom hours as MD’s and take the same basic sciences.”
Again, off topic. It would be counterproductive to derail the discussion of Protandim by enumerating all the deficiencies of a chiropractic’s education relative to those in the medical profession.
Hesu Whitten DC said: “As for Dr. Humphries, nephrologist, she…”
Has nothing to do with the topic of Protandim.
Hesu Whitten DC said: “If you read this one book, or even just the chapter on Polio, I’ll shut up and let you continue to be the know-it-all that you are (even though you probably are right most of the time).”
Not interested. Let’s get back to the subject at hand.
Hesu Whitten DC: “I’ll get back to you about autism.”
Please don’t.
Sander V says
@Vogel and LisaRob =>Nothing of what you say makes much sense.
You are not debunking Protandim at all, you are debunking yourself.
*The study on people with AUD doesn’t prove anything. It says nothing about the anti-oxidant properties of Protandim.
The study shows the removing of oxidative stress does not remove oxidative damage.
Oxidative stress can oxidize proteins (this is what happens in Cataract) but the removing of the oxidative stress does not repair the proteins. The removing of oxidative stress enable cells to heal .
Oxidized proteins can alter alveolar epithelial permeability.
http://www.ncbi.nlm.nih.gov/pubmed/22268125
*That study does not show that CUR doesn’t work.
It also shows you can’t revert oxidative damage by removing oxidative stress.
It showed an anti oxidant property of CUR.
“CUR attenuated lipid peroxidation in individuals with nondiabetic proteinuric CKD (P<.05) and enhanced the antioxidant capacity in subjects with diabetic proteinuric CKD (PBy not believing Protandim works, you deny 1000 years of experience, many lab-studies both on Protandim and it’s ingredients and many positive effects on people and dogs that use Protandim.
And the clinical trial does not debunk Protandim at all.
Vogel says
Sander V said: “@Vogel and LisaRob =>Nothing of what you say makes much sense.”
Rest assured that what we have said makes perfect sense to honest rational people. Your continued refusal to get the point would be astonishing were it not for the fact that we’ve seen this kind of deception and closed mindedness from Protandim distributors on a regular basis.
Sander V said: “You are not debunking Protandim at all, you are debunking yourself.”
Hardly! The debunking of Protandim has been quite thorough. There’s no argument left for you to hide behind.
Sander V said: *The study on people with AUD doesn’t prove anything. It says nothing about the anti-oxidant properties of Protandim.”
That’s head-scratcher of a comment since the abstract of the paper clearly contradicts your assertion. Is the problem that you can’t read or that you simply refuse to admit the truth? Allow me to quote the paper for the readers of this blog lest they fall prey to your deception.
“Additionally, among those with AUDs, no significant changes in BAL oxidative stress indexes, epithelial growth factor, fibroblast growth factor, interleukin-1β, or interleukin-10 were observed regardless of drug type received. Plasma thiobarbituric acid reactive substances, a marker of lipid peroxidation, decreased significantly over time among AUD subjects randomized to placebo (P < 0.01).”
http://www.ncbi.nlm.nih.gov/pubmed/22268125
It couldn’t have been stated clearer – no change in oxidative stress parameters and no change in TBARS/lipid peroxidation, except in the placebo group. You lose!
Sander V says
You are like a creationist that doesn’t believe in evolution. You interpret everything to fit your believes. You read but you don’t understand.
The removing of oxidative stress does not upregulate growth factors.
The only thing that says anything about the anti-oxidant activity of Protandim. is that they did not notice a reduction in BAL oxidative stress….there can be many explanations for this, it does not prove anyhing.
The anti-oxidant activity of Ashwagandha and green tea have been shown in clinical trials.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573577/
http://www.ncbi.nlm.nih.gov/pubmed/14519827
I don’t know if milk thistle has an anti–oxidant property but it definitely has proven positive effects.
http://www.ncbi.nlm.nih.gov/pubmed/17548793
This is about Turmeric.
http://www.ncbi.nlm.nih.gov/pubmed/23143785
Vogel says
Sander V said: “You are like a creationist that doesn’t believe in evolution. You interpret everything to fit your believes (sic). You read but you don’t understand.”
That’s a laughable accusation. I keep explaining the research findings to you and you keep denying them and making false statements about what the study data show.
Sander V said: “The removing of oxidative stress does not upregulate growth factors.”
That’s a non sequitur. I never said even mentioned the words “growth factors”
Sander V said: “The only thing that says anything about the anti-oxidant activity of Protandim. is that they did not notice a reduction in BAL oxidative stress….there can be many explanations for this, it does not prove anything.”
Except you are flatly wrong. The only explanation for making such a blatantly false statement is that you didn’t read the paper and are just commenting out of blind ignorance; or you read it and didn’t understand it; or you know what it says and you’re misrepresenting it on purpose.
Not only did the study report that Protandim had no effect on oxidative stress indices in bronchiolar lavage (BAL) fluid, it also stated that Protandim had no significant effect on plasma TBARS (oxidative stress) or on the level of antioxidants in plasma such as glutathione (GSH). It said:
“The thiol/disulfide pairs GSH/GSSG and Cys/CySS were measured in plasma from all 30 AUD subjects (Figs. 4 and 5)). Similar to what was observed in BAL, treatment with Protandim was not associated with significant alterations in GSH, GSSG, CyS, or CySS in plasma over the 7-day study period….Plasma TBARS (uM malondialdehyde equivalents) and PON-1 activity were measured from all 30 subjects (Fig. 6). A decrease in plasma TBARS over time was observed in both the Protandim and placebo groups that was statistically significant in the placebo group (P < 0.01).”
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330762/
Thus, this double-blind, randomized, placebo-controlled study was an epic failure for Protandim, as it contradicted the results of LifeVantage's non-blinded, non-randomized, non-controlled study published in 2006, which alleged that Protandim TBARS/oxidative stress in plasma and raised plasma glutathione levels.
http://www.ncbi.nlm.nih.gov/pubmed/16413416
Sander V says
Is it so hard to understand that oxidative damage doesn’t just disappear when you remove oxidative stress?
TBARS is a byproduct of lipid peroxidation, it doesn’t disappear when you remove oxidative stress.
Removing of oxidative stress prevents new TBARS to be formed.
There is only one way to measure oxidative stress and that’s by measuring ROS. (reactive oxygen species) ROS causes lipid peroxidation. You can remove ROS with anti-oxidant activity…..but that does not heal the damage ROS has caused.
All ingredients in Protandim have been proven to have positive effects…in clinical trials.
bacopa: http://www.ncbi.nlm.nih.gov/pubmed/18611150
ashwagandha:
http://www.ncbi.nlm.nih.gov/pubmed/23439798
green tea:
http://www.ncbi.nlm.nih.gov/pubmed/14519827
curcumin:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3535097/
milk thistle:
http://www.ncbi.nlm.nih.gov/pubmed/17548793
Also, doing clinical trials with Protandim is pointless. Clinical trials should be done on its ingredients separately.
Mike B. says
I have taken Protandim in the past (and I think it seemed to work at least in terms of helping me lower my cholesterol) but I will definitely say that they charge WAY TOO MUCH FOR SHIPPING the product. There’s no way that should cost like $9 to ship. No way. I have recently stopped being a customer to see if my cholesterol changes now….plus the S/H fee pissed me off.
Mike B. says
I thought LifeVantage had rules against folks buying it off ebay and the like, that it could only be purchased directly from distributors (who couldn’t alter the price)?
You have to admit that it sounds like a desperation move.
LisaRob says
I did look it over, but dismissed it as soon as I noticed it was an in vitro study of mouse neurons. At least the other study was on humans.
You need to look up what PubMed says about how important human studies are: http://www.ncbi.nlm.nih.gov/pubmedhealth/aboutcer/
Wow, that is quite a price drop for Protandim. It is usually closer to $50 a bottle. There must be a lot of desperate distributors selling it at a loss in order to maintain their position in the pyramid.
Even at the price you are paying, it is not a good value. The very first Turmeric supplement I found on Amazon (made by Purely Holistic) is much, much cheaper for what you get, has no fillers or stearates, and adds black pepper which, from what I’ve read, is needed for bioavailability. One bottle has 120 capsules, and each capsule has 350 mg of turmeric extract, as opposed to Protandim’s 75 mg. One bottle costs $29.95 and contains a total of 42,000 mg of turmeric extract. A bottle of Protandim would have 2,250 mg of turmeric extract and you are buying it for $22.25; not exactly a bargain.
There are no properly done human studies showing that Protandim “works” for anything. The person who actually did invent it (Paul Myhill), doesn’t even take it anymore. If you wish to keep throwing your money away on it, that’s your prerogative.
Vogel says
Sander V said: “I posted 2 studies, one of them is useless and unscientific but that’s apparently then only one you read.”
Actually, I read both but commented only on the human clinical trial because it’s the only one that’s relevant. Apparently you didn’t bother to read it; or you didn’t understand the implications of the negative results; or you read it and understood it to be a failure for Protandim but nonetheless presented it to us as though it validated the product.
Sander V said: “In the other study they prevent neurodegeneration by nrf2-activation which they reach by adding Curcumin.”
The “other study” you speak of was an in vitro study in isolated rat nerve cells. Ignoring for the moment that it was published in a journal (Neural Regeneration Research) so obscure that it has an impact factor of less than 1, the bottom line is that in vitro studies such as these have zero relevance to humans, and in fact, the human study you cited showed that curcumin did not affect NRF2 in the subjects who took it, and at a dose (320 mg) more than 4 times the amount that Protandim provides (75 mg).
That in vitro studies are unreliable and lack predictive value of effects in humans is a core concept in biomedical research. They are considered exploratory at best and are used to generate hypotheses for additional research; they are not adequately predictive of effects in humans and no scientist in their right mind would suggest otherwise.
The only acceptable proof is human clinical data, and there is none to suggest that Protandim has any therapeutic properties in people with neurodegenerative diseases. Not only that, but Protandim will never undergo the kind of clinical testing that would meet FDA standards for approval as a medicinal agent. The company has shown no such interest.
Sander V said: “I buy Protandim via ebay…it’s 89 dolllar for 4 bottles.(+shipping) That’s pretty cheap.”
The only reason you can get it that cheaply is because some sucker distributor probably had to load up on excess inventory to meet commission qualifications. At that price, you are getting it below distributor cost, which means you are capitalizing off someone else’s failure.
Sander V says
I see.
And why do you think those studies on rats are not acceptable proof for the nrf2-properties of Curcumin, Bacopa and Ashwagandha?
Do you really deny the anti-oxidant activity of the ingredients of Protandim?
Oxidative stress causes countless malfunctions in your body…like in all other mammals.
That’s why many plants and tress contain anti-oxidants and nrf2-activation…it’s an evolutionary trait.
Even milk contains nrf2-activation.
The price of Protandim is now lower then it used to be.
Vogel says
Sander V said: “I see. And why do you think those studies on rats are not acceptable proof for the nrf2-properties of Curcumin, Bacopa and Ashwagandha?”
No, you don’t see. I explained it in detail, and if you understood any of what I wrote you wouldn’t have asked that question. I went over the weaknesses of in vitro studies that drastically limit applicability to humans, and I explained how they are universally recognized by scientists as being unreliable for predicting effects in humans and are used only as tools to generate hypotheses for further research.
I also mentioned, in passing, that the in vitro study in rat cells was published in a journal with an impact factor so low that it could best be described as junk. Lastly, I pointed out that the human clinical study you posted about curcumin, which supersedes any test tube studies in terms of clinical relevance, indicated that it did not affect NRF2 even when given at a doses 4 times greater than Protandim provides.
This disparity between the negative results of the human study and the positive results of the test tube study, with respect to curcumin’s ability to stimulate NRF2, is a perfect example of why in vitro studies are not considered clinically meaningful, and why clinicians pay no attention to them.
The company is barred by law from using in vitro studies in the marketing of their products and they bear the burden of furnishing compelling evidence to the FDA to gain marketing approval as a medicinal agent and to support any claims about medical conditions that the product can allegedly treat. So it makes no sense to expect consumers to peruse the company’s in vitro studies and infer from them what the product may or may not do for medical conditions, and claims transmitted by distributors about the product having any therapeutic effects should be immediately dismissed with extreme prejudice.
Sander V said: “Do you really deny the anti-oxidant activity of the ingredients of Protandim?”
That’s a leading question, since I never said anything of the kind. Ingredients aside, I can say with certainty that Protandim itself was shown to be completely lacking in antioxidant activity in a human clinical trial that was published a couple of years ago but never discussed in the Protandim brochures – a glaring sin of omission.
http://www.ncbi.nlm.nih.gov/pubmed/22268125
The company has never published any clinical studies showing that Protandim activates NRF2 in humans, and now this other clinical trial you posted shows that curcumin doesn’t activate NRF2 even at a dose of 325 mg/day (greater than 4 times the 75 mg/day dose that Protandim provides). That’s enough damning evidence.
“Oxidative stress causes countless malfunctions in your body…like in all other mammals. That’s why many plants and tress contain anti-oxidants and nrf2-activation…it’s an evolutionary trait. Even milk contains nrf2-activation.”
Really? Are you going to lecture me about free radical biochemistry? Are you not aware that people have advanced degrees in this subject and spend decades studying it? You’re obviously not one of them. The sum total of your knowledge seems to have been hastily gleaned from a Protandim brochure.
The general mechanistic details you allude to are irrelevant. The issue at hand is one of direct evidence: i.e., is there reliable clinical evidence that Protandim has any medicinal benefits? The answer is no. In fact worse than no, because there is evidence now from two studies indicating that it doesn’t (i.e., the study of Protandim on pulmonary function in patients with alcohol use disorders and the study of curcumin in patients with renal disease). The secondary questions of whether Protandim has antioxidant effects or activates NRF2 is moot, but the prevailing evidence indicates that the product fails even in those respects.
Sander V said: “The price of Protandim is now lower then it used to be.”
Evidence? You said previously that you bought it at below wholesale price from E-Bay. Is it your contention that the price on E-Bay has gone down? If so, that’s a negative indicator – i.e., distributors are inventory loading to qualify for rank and commissions and then re-selling it at an even greater loss than usual.
The company’s price doesn’t seem to have gone down. This price list from February 2016 shows a retail price of $50 and a wholesale (distributor) price of $40 per 30-cap bottle, not including the hefty shipping charges. Those are the same hyper-inflated prices as always.
http://www.teamimt.com/?mdocs-file=1494&mdocs-url=false
Aside from the fact that Protandim doesn’t actually do anything, there is no justification, from the consumer’s perspective, for the extraordinarily high cost of the product, considering that it consists of tiny amounts of 5 very cheap and mundane ingredients. At wholesale prices, turmeric goes for about $220 per 100 kg.
http://www.business-standard.com/india/news/slight-decrease-in-turmeric-price/99786/on
A Protandim cap contains 75 mg of turmeric, which according to the wholesale price above, works out to a value of less than a thousandth of a penny. The other ingredients are similarly inexpensive – combined there’s probably no more than a penny’s worth of ingredients in each capsule but they retail for close to $2 per capsule with shipping, and an entire bottle likely costs the company around a buck or less, with packaging making up the bulk of the cost, and they then resell it at a ludicrous markup of roughly 50-fold.
Sander V says
You obviously think differently but the things you say don’t debunk the effects of Protandim in any way.
I hope you understand that the one who created Protandim did not invent anything.
They just brought together ingredients with a known anti oxidant activity…with anti-oxidants and nrf2-activation.
The ingredients of Protandim have been used for 1000s of years…
Vogel says
Sander V said: “You obviously think differently but the things you say don’t debunk the effects of Protandim in any way.”
On the contrary; the things I said directly debunked Protandim. In a randomized controlled clinical trial, it lacked antioxidant effects, failed to positively affect disease outcomes, and was never shown to activate NRF2. Similarly, curcumin, one of the principal ingredients in Protandim, did not activate NRF2 in human subjects at doses 4 times that provided by a daily Protandim pill and failed to positively affect disease outcomes, according to the study that you posted here. I have also pointed out various conclusive examples of the company’s business practices. The debunking of Protandim has been so complete that there is really nothing left to argue about, which is presumably why you have made no real attempt to do so.
Sander V said: “I hope you understand that the one who created Protandim did not invent anything. They just brought together ingredients with a known anti oxidant activity…with anti-oxidants and nrf2-activation.”
The product has a patent which lists very clearly who the “inventors” are – two people no scientific background whatsoever, and when it was released to market, there was no mention whatsoever about anything to do with NRF2, nor do any of the product’s patents mention NRF2. Here’s the patent:
http://www.google.com/patents/US7923045
Sander V said: “The ingredients of Protandim have been used for 1000s of years…”
So were arsenic and mercury and leeches.
LisaRob says
Vogel,
“The company is barred by law from using in vitro studies in the marketing of their products and they bear the burden of furnishing compelling evidence to the FDA to gain marketing approval as a medicinal agent and to support any claims about medical conditions that the product can allegedly treat.”
Check this out: http://www.nrf2science.com/cancer/
This website is by Lifeline Nutraceuticals, which is a subsidiary of Lifevantage. They quote a study on cancer and substitute “Protandim” with “Product 5x”. Then they wonder why distributors go around making illegal claims about their product. The whole site is like that.
Sander V says
I don’t understand why people discuss this.
It’s like discussing evolution.
The ingredients of Protandim have been proven to be nrf2-activators. ..especially curcumin.
http://www.ncbi.nlm.nih.gov/pubmed/26915483
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396114/
Vogel says
Sander V said: “The ingredients of Protandim have been proven to be nrf2-activators. ..especially curcumin.”
http://www.ncbi.nlm.nih.gov/pubmed/26915483
Apparently you didn’t read, or possibly just didn’t understand, the article you posted. Allow me to clarify what it said:
“No effect of CUR was observed on the antioxidant enzymes activities or Nrf2 activation.”
This directly contradicts what you said about being “proven to be Nrf2 activators.”
Additionally, curcumin had no therapeutic value whatsoever in this study (i.e., did not affect any of the primary endpoint measures of disease activity), as the authors reported:
“The intervention with CUR did not improve proteinuria, estimated glomerular filtration rate, or lipid profile…Unfortunately, our results were not completely satisfactory following this administration schedule (CUR 320 mg per day for 8 weeks), as biochemical and clinical parameters were not improved in both nondiabetic and diabetic proteinuric CKD…the pathological changes in clinical and biochemical profile have not been attenuated.”
All that curcumin did in this study was to mildly inhibit lipid peroxidation, which is consistent with the known direct antioxidant activity of curcumin but is of no apparent therapeutic value. A cheap vitamin C pill would do much the same thing.
Aside from that, even the antioxidant and lipoperoxidation data from this study were terrible (mismatched baselines, erroneous comparisons, noisy data, etc.) and it was published in an obscure lousy low-tier journal (Journal of Renal Nutrition).
Sander V says
I didn’t read that study.
Why didn’t you react on this study instead?
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396114/
Dr. Hesu Whitten DC says
Hi Vogel,
I have enjoyed your and Joe’s comments for the past many months. I don’t know why anyone would be silly enough at this point to make claims for the efficacy of Protandim. It’s like bare-handedly attacking someone who has a machine gun. Intellectual suicide.
Anyway, I would love to turn your critical analysis to the equally junk science that is being forced upon our children…vaccinations. This is a million times more vital to America’s welfare than some dying MLM. It is outright dangerous and may be responsible for the skyrocketing Autism rates. Also this year the government has taken away the parents’ right to sign a personal beliefs waiver to opt out of being vaccinated.
What the drug companies are attempting to do is make it so there are no unvaccinated children. Once that is accomplished there will be no possibility for a control group that could prove their injections are worthless or even dangerous.
If you have any interest in this topic please read Dr. Suzanne Humphries book “Dissolving Illusions” which was recommended by Dr. Mercola.
Keep up the good work!
Vogel says
Hesu Whitten DC said: “Hi Vogel, I have enjoyed your and Joe’s comments for the past many months. I don’t know why anyone would be silly enough at this point to make claims for the efficacy of Protandim. It’s like bare-handedly attacking someone who has a machine gun. Intellectual suicide.”
Nice of you to say. Thank you!
Hesu Whitten DC said: “Anyway, I would love to turn your critical analysis to the equally junk science that is being forced upon our children…vaccinations.”
Now why would you go and do a thing like that after getting off to such a nice start? Rule 1 is don’t derail discussions with off-topic subjects.
Hesu Whitten DC said: “This is a million times more vital to America’s welfare than some dying MLM.”
There’s no need to paint such a picture in terms of either/or. As a society, we have ample resources to tackle health issues and MLMs, and many other ills of the world, simultaneously.
Hesu Whitten DC said: “It is outright dangerous and may be responsible for the skyrocketing Autism rates.”
Except it’s not, and the science proves it. Ignore science at your own peril.
Hesu Whitten DC said: “Also this year the government has taken away the parents’ right to sign a personal beliefs waiver to opt out of being vaccinated.”
As I recall, this only happened in California, and I’m thankful it did. Just because someone holds the deluded belief that vaccines cause autism doesn’t mean that they should be allowed to put other children at risk.
Hesu Whitten DC said: “What the drug companies are attempting to do is make it so there are no unvaccinated children.”
Actually, no, that’s quite false. Drug companies put relatively little energy into promoting vaccinations because vaccines have sold themselves for decades based on their proven value for public health. Rather it is expert public health agencies, like the CDC and WHO for example, that promote vaccination programs.
Hesu Whitten DC said: “Once that is accomplished there will be no possibility for a control group that could prove their injections are worthless or even dangerous.”
The control groups have existed for more than 50 years, all the necessary data demonstrating efficacy have been gathered and analyzed, and the jury delivered its verdict long ago – an open and shut case.
Hesu Whitten DC said: “If you have any interest in this topic please read Dr. Suzanne Humphries book “Dissolving Illusions” which was recommended by Dr. Mercola.”
Mercola is a scaremongering idiot. His endorsement is a badge of shame. Why would anyone want to read a book about vaccines written by a nephrologist who has no expertise in immunology, virology, or epidemiology? That would be almost as dumb as taking vaccine advice from Jenny McCarthy.
LisaRob says
We discuss it because studies like the ones you listed have little, or nothing, to do with Protandim. They are used to dupe people into paying an outrageous price for an unproven product, and it supports a pyramid scheme. Even if Protandim activates Nrf2, it does not necessarily follow that there is a benefit to it. Some studies have shown that activating Nrf2 can be harmful.
We also discuss this because Protandim distributors are notorious for making false and misleading claims about the product.
However, looking at the dietary study you posted as proof that curcumin activates Nrf2, we see this:
“RESULTS:
The intervention with CUR did not improve proteinuria, estimated glomerular filtration rate, or lipid profile. However, in plasma, CUR attenuated lipid peroxidation in individuals with nondiabetic proteinuric CKD (P<.05) and enhanced the antioxidant capacity in subjects with diabetic proteinuric CKD (P<.05). No effect of CUR was observed on the antioxidant enzymes activities or Nrf2 activation."
I'm no scientist, but that last part says that Nrf2 was not activated. Also, they used 320 mg of curcumin, and Protandim has 75 mg.
Throwing out two irrelevant studies as proof that Protandim "works" for anything is pointless.
If curcumin is found (through properly conducted human studies) to be beneficial, you have to address the bioavailability, and the dosage. Curcumin is not expensive, so there is no need to buy an overpriced, overhyped curry pill sold through dubious means.
Sander V says
React on this study instead:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396114/
LisaRob says
Apparently you post studies without even reading them. Why should I (or Vogel) spend time on it, if you won’t?
Please analyze and present your argument on how this study (which you deem to be so important), applies to human beings swallowing a Protandim pill.
Like I said, I’m not a scientist, but I do know that an in vitro study of mouse neurons proves nothing about Protandim. That’s not how science works.
Sander V says
I posted 2 studies, one of them is useless and unscientific but that’s apparently then only one you read.
In the other study they prevent neurodegeneration by nrf2-activation which they reach by adding Curcumin.
In the medical world, Curcumin is many times proven to be a nrf2-activator.
When a cell is under oxidative stress, it will up-regulate the production of endogenous antioxidants to mitigate the free radicals. If it can’t, you need to take Nrf2-activator or take antioxidant supplements. If the cell is not fatally damaged, it will recover. Otherwise, it may undergo apoptosis.
In many degenerative diseases oxidative stress causes most symptoms.
Cataract is formed by the reaction between H2O2 and proteins.
Catalase is an enzyme created by nrf2 activation. Catalase degrades H2O2 in H2O and O2. Nrf2 in theory can prevent Cataract.
In spinocerebellar ataxia, nrf2-activation is very important.
Peripheral neuropathy can prevent with nrf2-activation and anti oxidants.
There are countless plants with nrf2-activators. The doses is often too low to be used in supplements or to be noted….the same goes for anti-oxidants.
I buy Protandim via ebay…it’s 89 dolllar for 4 bottles.(+shipping) That’s pretty cheap.