Mar 17, 2014Largest Nutritional Intervention Trial of Cocoa Flavanols and Heart Health to Be Launched
Brigham and Women's Hospital to lead novel collaboration with academic institutions, industry and the National Institutes of Health
BOSTON, MA - In a novel collaboration, Brigham and Women's Hospital (BWH), Seattle-based Fred Hutchinson Cancer Research Center, the National Institutes of Health (NIH), and Mars, Incorporated plan to partner on the largest research trial to date that will investigate the heart health benefits of cocoa flavanols. Once initiated, this large-scale, prospective nutritional intervention will evaluate the role of flavanols in reducing the risk of heart attack, stroke, and death from cardiovascular disease. Flavanols are naturally occurring plant-derived bioactive compounds found in cocoa beans and a variety of food sources. The study will also explore the effect of a daily multivitamin as compared to placebo, as a follow up to previous research conducted only in men, which suggested that multivitamins may lower the risk of cancer. This five-year study of 18,000 men and women nation-wide will also be the first large-scale randomized trial testing multivitamins in women.
"Cocoa flavanols and multivitamins are two of the most promising and exciting nutritional interventions available, and this new randomized trial is the natural next step in advancing our understanding of their potential benefits," says JoAnn Manson, MD, chief of the division of Preventive Medicine at BWH. "In smaller studies, cocoa flavanols have been linked to improvements in intermediate risk factors for heart disease, such as reductions in blood pressure and cholesterol levels, improvements in the body's sensitivity to insulin, and improved ability of blood vessels to dilate." Manson will co-lead the trial with Howard Sesso, ScD, MPH, also in the division of Preventive Medicine at BWH.
"For multivitamins, the exact mechanisms leading to lower risks of cancer remain unclear, but could be due to individual and joint effects of more than 20 vitamins and minerals," says Sesso. "This supplement has shown favorable results in research to date, but the proposed randomized trial is needed to provide conclusive evidence."
The proposed placebo-controlled randomized trial uses an innovative and highly cost-efficient approach to recruitment by including individuals who have already indicated their commitment to medical research by participating in other research studies. This allows for a rapid recruitment process and avoids the delays and high costs of recruiting new research participants.
Recruitment of women be done through the large nation-wide Women's Health Initiative and men will be recruited from other large population-based studies. This trial substantially increases the number of women included in randomized trials of interventions for prevention of cardiovascular disease and cancer, areas where inclusion of women has lagged. The recruitment process is slated to begin in fall 2014 and continue into 2015.
Mars, Incorporated will provide financial infrastructure support, together with the Heart, Lung, and Blood Institute of NIH, as well as the cocoa flavanol-containing capsules for use in this study. The collaboration with industry markedly reduces taxpayers' costs for the study.
"This collaboration represents the best of a public-private partnership in the interest of advancing science and public health. It's exciting to be at this turning point in scientific discovery where we have the potential to achieve benefits for some of our most significant health challenges today," said Harold Schmitz, Ph.D, Chief Science Officer at Mars, Incorporated.
The partnership between academic hospitals, NIH, and industry is expected to yield answers to its scientific questions by 2019.
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