Cocoa Supplement and Multivitamin Outcomes Study (COSMOS)
Cocoa flavanols, natural bioactive compounds in the cocoa bean, have been shown to have beneficial effects on cardiovascular disease (CVD) risk factors such as blood pressure, HDL and LDL cholesterol, insulin and inflammation, but we don’t know whether these effects will translate into real reductions in CVD rates.
Despite the prevalence of multivitamin use in the U.S. (over one-third of U.S. adults take multivitamins) they have not been shown to be effective at improving health. A recent large scale trial in male physicians found no effect on CVD but suggested that multivitamins reduced the risk of cancer by 8 percent. In older men (ages ≥ 70), the risk reduction was 18%. We are interested in determining whether these commonly used supplements can help reduce the risk of cancer, particularly in older women.
Starting in 2015, the Women’s Health Initiative (WHI) will be conducting a five-year, large-scale randomized controlled trial to test the effect of a concentrated cocoa extract and multivitamin supplements in reducing risks of CVD and cancer. This trial is the first study large enough to assess the effects of cocoa extracts and multivitamins on these health conditions that are so important in later ages. Researchers are interested in determining whether concentrated cocoa extract can help reduce heart disease and stroke and whether commonly used multivitamin supplements can help reduce the risk of cancer, particularly in older women.
Participants will be recruited from the WHI. However, there is a small chance that women not involved in the WHI may be eligible to participate. As a randomized controlled trial, participants will not know if they are taking cocoa flavanol supplements, multivitamin supplements or placebo pills. Placebo pills have no active ingredients.
The trial is coordinated by the Brigham and Women’s Hospital and the Fred Hutch. Involvement by Fred Hutch is through WHI, an ongoing nationwide study of postmenopausal women. This trial will showcase the ability of the WHI to conduct low-cost trials of non-invasive risk-reduction strategies in older populations by using the WHI's existing resources as the foundational structure.
The study will be sponsored by Mars Inc. and the National Heart Lung and Blood Institute (for core funding of WHI).
- Cocoa supplement is a highly concentrated extract of cocoa flavanols. This is not a study about eating chocolate.
- Multivitamin is a commonly used preparation
- Participants will be randomized to the cocoa extract or placebo and at the same time to a multivitamin or placebo
- Trial is randomized and controlled. Participants won't know if they are taking cocoa flavanol supplements, multivitamin supplements or placebo pills
- Study is 5 years
- The study is being sponsored by Mars, Inc. and the National Heart Lung and Blood Institute.
To ask questions, call 1-855-265-2932 or email to firstname.lastname@example.org.
You may ask questions anonymously or leave your name and contact information. Your name and contact information will be kept private by the Fred Hutch. Use is solely in regards to contacting you about the cocoa flavanol and multivitamin study. Leaving your name and contact information does not guarantee you will be contacted.
Learn more about the Women's Health Initiative.
For men who are interested in COSMOS, recruitment is focusing participants from the VITamin D and OmegA-3 TriaL (VITAL) at Brigham and Women’s Hospital, an affiliate of Harvard Medical School, in Boston, Massachusetts. Please contact Phillie Quinn at email@example.com.