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In This Issue:
JoAnn Manson
You don't have to be a chocolate lover to have heard of the cocoa bean, which is where the popular treat comes from. What you might not know is that the cocoa bean contains naturally occurring bioactive compounds called cocoa flavanols, which have been associated with health benefits.
In a novel collaboration, BWH will conduct the largest research trial to date to investigate the heart health benefits of cocoa flavanols by administering the concentrated nutrients in capsule form. These nutrients are often destroyed during processing but will be preserved in this study using a special technique. Once initiated, this large-scale nutritional intervention will evaluate the role of flavanols in reducing the risk of heart attack, stroke and death from cardiovascular disease in 18,000 women and men nationwide. The Seattle-based Fred Hutchinson Cancer Research Center, the National Institutes of Health (NIH) and Mars, Incorporated are partners in the trial.
The study will also explore the effect of a daily multivitamin compared to a placebo, as a follow-up to previous research conducted only in men that suggested that multivitamins may lower the risk of cancer. This five-year nationwide study will be the first large-scale randomized trial of multivitamins that includes women.
"Cocoa flavanols and multivitamins are two of the most promising and exciting nutritional interventions available, and this new trial is the natural next step in advancing our understanding of their potential benefits," said JoAnn Manson, MD, DrPH, chief of the Division of Preventive Medicine at BWH and the Michael and Lee Bell Professor of Women's Health at Harvard Medical School. "In smaller studies, cocoa flavanols have been linked to improvements in 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 of BWH Preventive Medicine.
The proposed placebo-controlled trial uses an innovative and cost-efficient approach to recruitment by including interested individuals who have participated 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 will be done through the 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 cocoa flavanol-containing capsules for use in this study. Study infrastructure support will be provided by both the NIH's National Heart, Lung, and Blood Institute and Mars, Incorporated.