A client asked me about a new supplement her friends were recommending. It's a pill called Protandim that's supposed to be a revolutionary anti-aging breakthrough. A short sales pitch on the pill was accompanied by a video of an ABC program called Primetime Live with co-anchor John Quinones.
In the first two minutes of the video, we are introduced to "world-renowned scientist" Dr. Joe McCord of the Webb-Waring Antioxidant Research Institute. Mr. Quinones says, "[Dr. McCord's] latest research could very well unravel the mystery of aging itself. And his decades of experiments may have the potential of adding years to peoples lives and possibly prevent chronic diseases like cancer, diabetes and heart disease. It all centers around this small yellow pill..."
In the video, Mr. Quinones talks about the potential of Protandim and even agrees to take it and see what the pill will do for him. I had to find out more.
Protandim is a patented dietary supplement marketed by LifeVantage Corporation. In the 2005 patent application, they claim "the invention safely induces cellular antioxidant potential to achieve an overall net decrease in oxidative stress..." Simply put, this pill supposedly slows down one of the mechanisms of aging.
Exactly what's in Protandim?
According to the patent application, it contains a creeping herb called "bacopa monniera extract; milk thistle extract, ashwagandha powder, green tea extract, Gotu kola powder, Ginko biloba leaf extract; Aloe vera powder; turmeric extract; and [the antioxidant] N-acetyl cysteine."
There are LOTS of problems, and the first one is the ingredients. Although the patent application lists nine ingredients, the final product only contains five of the original nine. They are:
- Milk thistle extract (225 mg)
- Bacopa extract (150 mg)
- Ashwagandha root (150 mg)
- Green tea extract (75 mg)
- Turmeric extract (75 mg)
That means the product they patented, isn't the one they're selling.
(LifeVantage also lists on its website the other ingredients of Protandim as Microcrystalline Cellulose, Croscarmellose Sodium, Silica, Modified Cellulose, Stearic Acid, Magnesium Stearate, Maltodextrin, Medium Chain Triglycerides.)
What does the clinical research say about Protandim?
Thirteen peer-reviewed research studies of Protandim have been published as of 2013; all but two were conducted in "test tubes" or using animals. I was excited to see what the two human trials showed.
The first human trial was published in the journal Free Radical Biology and Medicine in January of 2006. All the subjects knew the ingredients they were taking and were aware of their supposed potential. It's no big surprise that the results of that trial were positive.
The second human trial, published in 2012, was far more rigorous. It was a double-blind, placebo-controlled and randomized trial. That means the subjects were divided into two groups. One group got the supplement, while the other got a fake pill. Neither the researchers who were giving the pills or the subjects getting them, knew if they had the real or fake supplement.
Protandim failed. Even though researchers gave subjects twice the recommended daily dose, at the end of the study, Protandim had "no significant effects" on oxidative stress, epithelial growth factor, fibroblast growth factor or anything else they were measuring.
(You can read the study for yourself at the link here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330762/)
It reminds me of what happened with antioxidant pills. When they were first released, it was believed they might be an anti-aging breakthrough. But when clinical trials were conducted (AFTER the supplements were already being sold), researchers found out the pills caused people to die SOONER than when taking a placebo. Antioxidant supplements weren't just worthless, they were harmful.
PLEASE NOTE: I am NOT saying Protandim is harmful, there is no evidence of that. What I am saying about Protandim is the same thing I've said about ANY supplement. There should be clear clinical evidence, provided by a double-blind, placebo-controlled study on humans, that it's both safe AND provides a medical benefit to the person taking the supplement.
The 2012 human trial is never mentioned by anyone selling Protandim. It got me wondering about the ABC Primestime Live video. When was it made? The link I got on YouTube said it was posted in 2014. However, a simple search turned up the same video, posted dozens of times over several years. Because the video has no date on it, continuously reposting it to YouTube makes it look current. In fact, the segment was shot in 2005, before the exciting promise of that "small yellow pill" failed to materialize.
What changed is how the pill is sold. In 2005 LifeVantage sold Protandim through traditional retailers like GNC. Very few people bought it. After years of losses, LifeVantage switched to multilevel marketing and started selling Protandim through a network of independent distributors.
That's how it came to my attention. With an army of people pushing Protandim, testimonials blossom as people share their "miraculous" stories about what the pill did for them. None of them were backed by clinical trials, but we all SO want to believe.
Perhaps the most important statement made about Protandim came from Dr. Joe McCord in that Primetime Live video so many years ago. He said, "We make no claims about curing any disease or preventing any disease. We hope that when enough studies are done, perhaps such claims might be able to be made in the future."
Ten years later, those claims still cannot be made.
Until there are double-blind, randomized, placebo-controlled studies that show Protandim can HELP and doesn't HARM, it is our recommendation that you stay away. Spend your money on products that HAVE been proven.
The side effects of Protandim may include allergic responses, gastrointestinal disturbances (stomach ache, diarrhea, vomiting), headache, and rash of the hands and feet.
As the Primetime Live video continues to be reposted, people are embellishing the title to include phrases like "Protandim - Proven to work on ABC Primetime." Of course if by "work" they mean it's an effective anti-aging supplement, then they're lying. As the research so far proves, it does no better than a placebo when tested in real people in a clinical trial.
In December of 2012, LifeVantage recalled 247,896 bottles of Protandim because of "possible inclusion of small metal fragments in the final product." In February of 2013, the recall was expanded to include additional lots of the product. It's disturbing when a pill, marketed as a life-enhancing medicine, is manufactured under such poor quality control that "metal fragments" may make their way into the final product.
Nutritionist Elizabeth Somer, TV personality Montel Williams and Donny Osmond currently are or previously have been hired as paid spokespersons for Protandim. Any videos or news stories involving these people and Protandim must be considered nothing more than commercials or paid endorsements of the product.
On April 17, 2017, the company that markets Protandim (Lifevantage Corp) was sent a letter by the U.S. Food and Drug Administration. Lifevantage Corp was told to remove the claims on their websites that Protandim could do things like prevent diabetes, Alzheimers or cancer.
You can read the letter HERE on the FDA website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lifevantage-corp-510546-04172017
You can download a PDF version of the letter here: FDA Warning Letter to Lifevantage Corp.
To legally make those claims, Protandim would have to be classified as a drug, and there would need to be clinical trials proving those claims. Then it would have to be approved by the FDA. Of course, none of those things happened. Six years after we first asked for a double-blind, placebo-controlled trial ON HUMANS to prove Protandim has any benefit, that still has not been done.
You will notice there is a change on their website. Now all Lifevantage Corp claims use words like support, protect, promote and enhance. Supplement companies can use those words because, from a medical standpoint, they mean nothing.
I can claim licking a wooden spoon will support my immune system, promote clear thinking, enhance my daily energy and boost my health. I would not get in trouble with the FDA because those words are medically meaningless. That’s why you’ll find them sprinkled liberally throughout supplement websites.
Just to be extra careful, at the end of every sentence on the pages talking about Protandim is an astrix with a disclaimer, in much smaller text at the bottom of the page. It says, “* These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.”
That’s DIRECTLY from the makers of Protandim. Years after they released their product, they STILL cannot claim that their products can “treat, cure or prevent ANY disease.” If they can’t say it, why are people still believing it?
Don't write us, call us or email us until you've got that study. And make sure it's done on at least 100 people, for a minimum of 6 months.
On the Science Based Medicine website they say about Protandim: "Its patent application said it was useful to treat or prevent an astounding 126 diseases and medical conditions, from tinnitus to aging, from hemorrhoids to cancer. Those claims are not supported by any credible scientific evidence."
You can read their review of Protandim here: https://sciencebasedmedicine.org/protandim-update-new-studies-and-an-fda-warning-letter/
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