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Largest Nutritional Intervention Trial of Cocoa Flavanols And Hearth Health To Be Launched

Monday, March 17, 2014

Study brings together academia, industry and the National Institutes of Health

BOSTON, Ma. – In a novel collaboration, Brigham and Women’s Hospital, the 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 investigating the 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 in 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 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.”

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 placebo-controlled, randomized trial of 18,000 men and women. Women in the trial will be recruited from the nationwide Women’s Health Initiative and men will be recruited from other large population-based studies.

“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 proposed 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 participants from scratch. Dr. Garnet Anderson will collaborate at Fred Hutchinson Cancer Research Center for this research. The collaboration with industry markedly reduces taxpayers’ costs for the study.

The partnership between academic hospitals, NIH, and industry is expected to yield answers to its scientific questions by 2019.

About Brigham and Women's Hospital

Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people. The Brigham’s medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $650 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation’s first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information, resources and to follow us on social media, please visit BWH’s online newsroom.