How to show a clinical trial benefit in healthy populations
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.
