New landmark study to examine role of cocoa flavanols in maintaining cardiovascular health

Recognizing that heart health is one of the world's most significant public health challenges, Mars, Incorporated, in collaboration with Brigham and Women's Hospital (BWH), a teaching affiliate of Harvard Medical School, is launching a five-year landmark study to examine the role of cocoa flavanols, plant-derived bioactives from the cacao bean, in helping people maintain cardiovascular health. Ancillary studies will focus on a broad range of potential benefits of cocoa flavanols on brain health, including memory, decision-making skills, mood, and cognitive performance, as well as metabolic health.

This randomized placebo-controlled trial, called the COcoa Supplement and Multivitamin Outcomes Study (COSMOS), will enroll 18,000 women and men nationwide, making it the largest dietary intervention study to evaluate the health benefits of cocoa flavanols and a multivitamin. The study is the result of an innovative public-private partnership among BWH, Harvard Medical School, the Seattle-based Fred Hutchinson Cancer Research Center (FHCRC), the National Institutes of Health (NIH), Mars, Incorporated and Pfizer Inc.

For the past 20 years, Mars, Incorporated and its network of collaborators have built an international research network aimed at pioneering and sharing leading science and innovation to advance the understanding of cocoa flavanols and their impact on human health. Mars, Incorporated is providing financial infrastructure support together with the Heart, Lung and Blood Institute of the NIH, as well as the cocoa flavanol-containing capsules for use in this trial. The capsules are prepared specifically for research purposes and are produced using Mars' proprietary Cocoapro® process to extract flavanols from cocoa beans.

"Our research group has extensive experience in evaluating the impact of large-scale dietary interventions on cardiovascular health," explained JoAnn Manson, MD, Chief of the Division of Preventive Medicine at BWH and co-lead on the study. "The COSMOS trial builds on a decade of scientific evidence indicating that cocoa flavanols improve blood vessel function, metabolic health and cognition. The depth and breadth of this innovative trial are unprecedented. "

Howard Sesso, ScD, also from the Division of Preventive Medicine at BWH and co-lead on the study, added, "This is an exciting time for nutritional intervention research, as cocoa flavanols are among the most promising bioactives based on research to date."

Women in the trial will be recruited from the nationwide Women's Health Initiative starting in May 2015, and men will be recruited from other large population-based studies conducted through the BWH Division of Preventive Medicine. Others interested in participating can call 1-800-633-6913 (to be eligible, men must be at least 60 and women at least 65 years of age). The partnership among academic hospitals, NIH and the industry is expected to begin to yield answers to its scientific questions by 2019.

"Mars has a long-term commitment to cocoa flavanol research," noted Dr. Hagen Schroeter, Director of Fundamental Health & Nutrition Research, Mars, Incorporated. "We take a multidisciplinary approach to research and collaborate with a broad platform of top researchers and scientific institutions around the world from government and academia. We believe that this collaboration represents the best of a public-private partnership intended to address one of society's most significant health challenges."

COSMOS will also explore the effect of a daily multivitamin on lowering the risk of cancer, following up on promising trial findings reported among men from the Physicians' Health Study II. It is the first large-scale randomized trial testing of multivitamins in women.