Protocol for a randomized, controlled trial of a bioactive dietary polyphenol preparation to promote resilience in...

Botanicals and nutritional supplements have gained tremendous popularity as natural approaches to enhancing physical and mental health. However, alongside this trend, there is a growing recognition of the importance of rigorous human studies to validate the absorption, bioavailability, safety and physiological effects of these botanicals. Understanding the effects of these compounds on stress-related outcomes is crucial for ensuring their efficacy and safety to promote stress resilience and overall health. This report describes the design of a parallel arm, randomized, double-blind, placebo-controlled clinical trial to assess the absorption and bioavailability of a 5-week intervention of a daily Bioactive Dietary Polyphenol Preparation (BDPP) consisting of Concord grape juice (CGJ), grape seed polyphenol extract (GSPE), and trans-resveratrol (RSV). Healthy adults (ages 18-55 years) are randomized to receive low, medium, or high doses of BDPP or matching placebo. In addition to pharmacokinetic profiling, the study will evaluate the effects of BDPP on immune function and behavioral measures of stress. The trier social stress test (TSST) will probe acute response to stress. Findings from this trial are intended to lay the foundation for future, larger studies of BDPP and other natural polyphenol-rich products investigating the clinical utility of phenolic supplements for stress resilience and health.