NCT05232669

COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance

COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21,442 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improve musculoskeletal health and prevent falls and declining physical performance in the increasing number of older adults in the U.S. with potential for clinical and public health benefits.

Conditions

• Fall
• Physical Performance
• Fracture

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cocoa extract	2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
DIETARY_SUPPLEMENT	Cocoa extract placebo	Cocoa extract placebo
DIETARY_SUPPLEMENT	Multivitamin	Multivitamin
DIETARY_SUPPLEMENT	Multivitamin placebo	Multivitamin placebo

Timeline

• Start date: 2021-05-15
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2022-02-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States