Cocoa extract may reduce the risk of heart disease and stroke in older adults — but we don't know for sure. We also don't know if taking multivitamins helps reduce the risk of cancer. WHI investigators have received funding to study these questions in both women from the WHIand in men and women recruited through Brigham and Women's Hospital and Harvard Medical School in Boston. The scientific leadership team includes Drs. JoAnn Manson, MD, DrPH, and Howard Sesso, ScD, of Harvard and Brigham and Women's Hospital in Boston, and Dr. Garnet Anderson, PhD, from the WHI Coordinating Center at Fred Hutchinson Cancer Research Center in Seattle. Funding and other support is being provided by Mars Symbioscience Inc. and Pfizer Inc.
COSMOS is for women 65 years or older and men 60 years and older. No prior heart attack ever or cancer during the past two years.
See www.cosmostrial.org for more information and an opportunity to sign up for the study. You may also contact the COSMOS team at Brigham and Women’s Hospital by email at firstname.lastname@example.org or by phone at 1-800-633-6913.
WHI invitational letters have been mailed and WHI recruitment is well
Eligible persons who consent will be assigned at random to one of these four COSMOS intervention groups:
Participants will not be told their COSMOS intervention group assignment.
Participants will take the COSMOS study pills for 4 years.
The COSMOS study pills with cocoa extract will not taste like chocolate.
The COSMOS study pills with multivitamins will be similar to commonly available multivitamin supplements.
Being 65 years or older and currently enrolled in the WHI.
Not having had a heart attack or stroke.
Not having been diagnosed with cancer in the past two years.
Being 65 years or older.
Being 60 years or older.
Willing to stop taking concentrated cocoa extract supplements during the study if you are currently taking it on your own. It is OK to drink regular cocoa beverages and eat chocolate.
Willing to stop taking multivitamin supplements, including multivitamins for eye health (for example, PreserVision or Ocuvite) during the study if you are currently taking them. It is OK to take calcium supplements up to 1200 mg per day and Vitamin D supplements up to 1000 IUs per day.
The extract from cocoa beans contains rich natural bioactive compounds called flavanols.
There have been hints over the years that cocoa might have health benefits. Some small clinical trials have shown that cocoa extracts can improve cholesterol, blood pressure and other vascular risk factors. But so far, no one has shown whether that translates to fewer cardiovascular events, including heart attacks and strokes.
Evidence about multivitamin use and health is lacking.
In the WHI, multivitamin use has not been found to influence the risk of cancers or heart disease.
Women's Health Initiative Publication on Multivitamins and Cardiovascular Disease and Cancer
A large scale trial in male physicians found no effect on cardiovascular disease, but did report that a daily multivitamin reduced the risk of cancer by 8 percent. In older men (ages ≥ 70 years), the risk reduction was 18%..
Physicians' Health Study II Trial Results on Multivitamins and Cancer
Interested in more information? See the COSMOS Trial website at www.cosmostrial.org.
Women 65 years and older, not having had a heart attack and not having had cancer during the past two years: Call 1-800-633-6913 or email COSMOStrial@partners.org.
Men 60 years and older, not having had a heart attack and not having had cancer during the past two years: Call 1-800-633-6913 or email COSMOStrial@partners.org .
Does increasing physical activity in postmenopausal women lower the risk of heart disease? Help maintain independent living?
WHI received funding to find out if increasing physical activity in older women improves health.
WHI will use the information you have provided to see if you might be eligible for WHISH.
Potentially eligible WHI participants will be contacted about WHISH in 2015.
Some women will be contacted for both WHISH and COSMOS. You may take part in both studies.
If you join WHISH, you may be asked to move more and sit less. This might include:
Walking or similar activity — ones that you enjoy.
Strength, balance and flexibility activities.
Setting your own goals.
Your WHISH participation would be for 4 years.
WHISH will be done by mail and phone.
WHISH Scientific Leaders: Marcia Stefanick from Stanford, Charles Kooperberg from the WHI Coordinating Center at the Fred Hutchinson Cancer Research Center and Andrea LaCroix from the University of California at San Diego.
WHISH Sponsor: The National Institutes of Health