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

NCT05232669 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21442

Last updated 2026-04-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Meryl S LeBoff, MD · Brigham and Women's Hospital

  • Carolyn Crandall, MD, MS · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232669 on ClinicalTrials.gov