In the news: COSMOS: Promising CVD Effects of Cocoa, Multivitamins Tied to Cognitive Benefits

The COSMOS and COSMOS-Mind Trials

The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is a large-scale trial conducted by researchers from Harvard and the Fred Hutchinson Cancer Center and designed to assess the effects of a cocoa flavanol extract and/or a multivitamin on cardiovascular disease (CVD) and cancers.

The study results, published this month, suggest that cocoa flavanols may offer protective cardiovascular effects(1,2).

Trial Design & Results from COSMOS

COSMOS is randomized, double-blind, placebo-controlled trial of 21,442 U.S. adults (12,666 women aged ≥ 65 years and 8776 men aged ≥ 60 years) free of major CVD and recently diagnosed cancer. Using a 2 x2 factorial design, participants received either 500 mg/day of cocoa extract flavanols and a daily ‘multi’, the cocoa extract and placebo, the ‘multi’ and placebo, or two placebos. The median follow-up was 3.6 years.

Neither supplement reduced the risk of the primary endpoint, a composite of total cardiovascular (CV) events. However, the cocoa flavanol group had a significant 27% reduction in death from CVD, a secondary endpoint.

Further, when looking at participants who took their treatment pills regularly (per-protocol analyses), the cocoa extract group showed a 15% reduction in total CV events and a 39% reduction for CVD death.

Neither supplement reduced the primary endpoint of total invasive cancer, although it is unlikely that the study period was long enough to detect an impact on cancer risk.

COSMOS-Mind Trial

COSMOS-Mind is an ancillary cognitive study led by Wake Forest School of Medicine investigators in collaboration with Harvard to examine whether cocoa flavanols and/or multivitamins benefit cognitive function in older adults.

COSMOS-Mind preliminary results, presented late last year at the 14th Clinical Trials on Alzheimer’s Disease conference, indicate that a daily multi-vitamin may slow cognitive aging, particularly in those with CVD(3,4).

The sub-study included 2262 COSMOS participants aged 65 and older (mean age of 73 at baseline) who were free of dementia. Participants underwent cognitive testing at baseline and annually for 3 yrs. Cognitive scores were similar between groups at the study’s start.

The researchers saw no effect of cocoa extract vs placebo on Global Cognitive Function composite score, the primary outcome. However, the multivitamin was associated with a 60% slowing of cognitive aging, the secondary outcome.

The findings were similar for the multivitamin group with respect to memory composite scores and executive function composite scores, two additional outcomes. Looking at treatment effects for prespecified subgroups, multivitamins had a more pronounced benefit on cognitive aging in those with a history of CVD. Participants with previous CVD taking placebo continued to show cognitive decline.

More Ancillary Studies to Come

The research team is planning additional COSMOS sub-studies such as assessing the effect of these supplements on falls, cognitive decline, and biomarkers of aging. One ancillary study underway, COSMOS-Eye, is examining whether the cocoa extract or multivitamin reduces the risk of cataract and AMD, two leading causes of visual impairment in US men and women.

References

1. Sesso HD, et al. Effect of cocoa flavanol supplementation for prevention of cardiovascular disease events: The COSMOS randomized clinical trial. AJCN. Ahead of print, Mar. 16, 2022.
2. Sesso HD, et al. Multivitamins in the prevention of cancer and cardiovascular disease: The COSMOS randomized clinical trial. AJCN. Ahead of print, Mar. 16, 2022.
3. 14th Clinical Trials on Alzheimer's Disease (CTAD) conference: Oral Communications (OC) #4. Presented November 10, 2021.
4. Anderson P. Multivitamins, but Not Cocoa, Tied to Slowed Brain Aging. www.medscape.com/viewarticle/962772.