Andrew Shao, PhD, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), told NutraIngredients-USA.com that industry must become involved in discussions on nutritional supplement testing.
Testing supplements is far from straightforward and presents a host of awkward questions. How do you measure vague but popular concepts like “wellness”? How can you apply the reductionist approach of isolating a single compound to botanical supplements containing a combination of extracts that supposedly to work in synergy?
And more broadly how do you apply the rigor of randomized clinical trials (RCTs) to dietary supplements?
Creating a genuine placebo group for an RCT of a nutritional supplement is just impossible. Shao said that doing so would deprive the people in the placebo group of important nutrients – hardly a defensible move on moral grounds.
These testing hurdles were discussed last week at a CRN event called The Workshop: A Day of Science. Leading scientists and academics from the field spoke, including Paul Coates, PhD, and Joseph Betz, PhD, both from the Office of Dietary Supplements (ODS) and National Institutes of Health (NIH).
Shao said the scientific symposium helped practitioners understand some of the problems facing researchers and set the stage for more industry discussion. He said: “There were a lot more questions than answers but that leaves a lot of opportunity for future dialogue and engagement.”
Need for dialogue
What is needed, according to Shao, is a step back and a moment of reflection to determine what questions trials should answer and then work how best trials should be designed.
So dialogue and reflection is needed before going ahead with “big home run” randomized trials, but what should be done in the meantime? Companies still need to market their products.
Shao said supplement makers have to rely on what is available and at the moment there is plenty of good observational data for companies to use. In the future though, better questions, better designed test, better characterizations, should help the industry give customers stronger reassurance that their products work.