Clinical Trials of the Year for Dietary Supplements

Clinical trials have been a touchy subject in the health and wellness industry. It’s not that supplement and functional-food manufacturers oppose rigorous inquiries into the details of their products’ efficacy; it’s just that, for a while there, the U.S. FTC was interpreting the “competent and reliable scientific evidence” standard that it requires of manufacturers to substantiate a structure-function claim to mean “at least two adequate and well-controlled human clinical studies.”
While the FTC appears to have dialed back somewhat on this interpretation, it’s understandable that it initially set industry back on its heels. After all, as any researcher will attest to, even one well-controlled human clinical study-to say nothing of two-is incredibly complex, time-intensive, not to mention expensive to do. Such randomized controlled trials (RCTs) take a long time and a large number of participants to carry out. And they aren’t even always appropriate-or necessary-for answering the questions or establishing the knowledge that researchers or industry seeks.
But there’s a reason the National Institutes of Health (NIH), the FDA, and other august bodies deem RCTs the gold standard of clinical research-several reasons, in fact. Some consider such large-scale, randomized, controlled human studies indispensable for revealing consistent, unbiased information about a supplement’s effects, allowing us better to determine appropriate dosing, understand a mechanism of action, and elucidate benefits. And, for those who require them, RCTs burnish the legitimacy of an industry that often finds itself on the defensive.
But perhaps most importantly, RCTs have the potential to improve lives. “This is the type of research that needs to get into the hands of doctors, so they can make use of it in their practice,” says Harry B. Rice PhD, vice president of regulatory and scientific affairs, GOED (Global Organization for EPA and DHA Omega-3s; Salt Lake City). “Solid proof can only be obtained by conducting well-designed clinical trials.”
Rice and others share their candidates for some of the most notable human clinical trials of the year.
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