One common question I get asked is why are there no large scale human clinical with Protandim? The answer is pretty easy, but I have to answer this with some history.
When Dr McCord first formulated Protandim, he knew that it worked.. in vitro (test tube experiments) proved extremely positive. The desire to see if this translated into something that would work with living people was strong. So to that end, a simple clinical was done, small scale, and included a few dozen people by random, largely those available to him at the university or in the lab. He gave no instructions on how to take it, but simply take one pill per day. The purpose ofthe study was to find out, what effect if any Protandim would have in vivo (in the living).
The results were remarkable. Everybody in the study had their oxidative stress levels (as tested by TBARS) reduced to the level of a child. We use the phrase 100% of the people 100% of the time, and this was the case. The study was never meant to be a large scale FDA style study. It was simply meant to see if Protandim would work in people. So the question remains, why not a larger scale clinical as we typically see with FDA studies that involve thousands?
From 2003 until (frankly now), the company was in debt. The cost associated with an FDA large scale clinical would be financially exhaustive and literally impossible. During the same period over 25 studies started being done by third parties, (with McCords assistance in some cases). Because of the nature of the funding by those researchers are small, most chose mammal studies (like the LSU study) or in vitro studies (like the Ohio State study). LifeVantage didn’t dictate to these researchers in what manner they will study Protandim’s effects with their subject of interest.
However, we do know some of these studies are human clinicals, and we wait for these results on the time-table determined by the peer review process. However, we should not forget, the largest scale human clinical are the 10′s of thousands of customers who take Protandim who are not involved in the business. While we don’t gather statistics on their experience, we should know that they’re experience is likely a positive one, else they would not continue to take Protandim with the attrition rates, and the huge positive feedback given. Because the supplement industry is regulated, these testimonials rarely surface in public forums, yet these testimonials exist in spades.
So what will the future be with human clinicals and Protandim? I suspect as the company grows (being cash flow positive) and research focus takes hold, investments in larger scale clinical will occur. We do know that other Nrf2 activator drugs like BG-12, are found to be very effective against Multiple Sclerosis, studies that compare in vitro Protandim to BG-12, show Protandim to be more effective, so, while no statistical conclusion is available (yet), the results look very promising with other large scale clinicals for Nrf2 activators (even if they are synthetics, Protandim being all natural). In the months and years ahead, we’ll see many more studies come out that include Protandim, some will be clinicals. Be patient, and be glad that the world doesn’t know about it yet.