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

Not Applicable

Active, not recruiting

• Conditions: Physical Performance; Fall; Fracture
• Interventions: Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin; Dietary Supplement: Multivitamin placebo

• Registration Number: NCT05232669
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-15
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21442

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cocoa extract + multivitamin	Multivitamin	-
Cocoa extract placebo + multivitamin	Cocoa extract placebo	-
Cocoa extract + multivitamin placebo	Multivitamin placebo	-
Cocoa extract placebo + multivitamin placebo	Cocoa extract placebo	-
Cocoa extract placebo + multivitamin placebo	Multivitamin placebo	-
Cocoa extract + multivitamin	Cocoa extract	-
Cocoa extract + multivitamin placebo	Cocoa extract	-
Cocoa extract placebo + multivitamin	Multivitamin	-

Primary Outcome Measures

Name	Time	Method
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)	5 years
Recurrent falls (2 or more falls per year)	5 years

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States