07.01.10
Participants in a workshop sponsored by the National Institutes of Health (NIH) have developed guidelines on designing and evaluating clinical research studies investigating soy, representing the first guidelines of their kind in the field of soy research. The guidelines were published in the June 2010 issue of The Journal of Nutrition. They represent a tool for increasing the consistency of study design and validity of outcomes in future clinical research on soy. Past results of clinical studies on soy have been inconsistent and difficult to compare, which could be attributed to a number of factors, including varying product composition and dosing, study adherence and sample size. The new guidelines are intended to improve the quality of future research studies of soy. The soy research guidelines address: the need for sound justification for studying the health effects of soy in humans; approaches to understanding and ensuring product composition and integrity; methods for assessing exposure to non-study soy and intervention adherence; some appropriate analytical methods to test soy products; the importance of understanding how soy is processed and how it acts in the body; and the role that genetic make-up may play in the health effects of soy.