How to show a clinical trial benefit in healthy populations


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By applying physiological stressors like partial sleep deprivation, it is possible to test the effects of dietary supplements in healthy populations and stay compliant with DSHEA, says Dr Jay Udani, CEO of Medicus Research.

Speaking with Stephen Daniells at the recent SupplySide West show in Las Vegas, Dr Udani explained his Udani Theory of Natural Health Products Clinical Trial Design.

Dr Udani breaks his theory down into three parts: First, identify healthy or at-risk population; second is to apply a physiological stressor to overwhelm their normal physiology; and third is to select end-points that are relevant not only to a scientist, but also to regulators and consumers.

“In clinical trial design, to stay compliant with DSHEA you have to have a healthy population that is not diseased,”​ he explained. “But if someone is so healthy, how do you actually show a benefit for your dietary supplement?”

Providing a couple of examples, Dr Udani said that boomers displaying a little slowing down in their mental processing and recall could be used as subjects in a cognitive function trial. By applying a physiological stressor like partial sleep deprivation or some kind of psychological stressor like playing a video game.

“At that point of physiological stress you start to see the difference between healthy, at-risk, and diseased. They’re clearly not diseased, but they’re hedging towards at-risk,” ​he said.

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1 comment

Expanding the principe

Posted by Robert DiSilvestro,

I have also been a strong supporter of the research approach of acute stress in healthy people. However, besides sleep deprivation, there are other less harsh treatments that can be used to test functions such as immunocompetence, resistance to inflammation, alertness reactions, cognitive function, eye health, and others. Some of the stressors can be induced experimentally. In some cases, one can also take advantage of circumstances that are already occurring in selected subjects.

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