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

April 10, 2026 updated by: Meryl LeBoff, Brigham and Women's Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21442

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

  1. Participants who reported an injurious fall resulting in healthcare utilization (visit to a healthcare provider or hospital)
  2. Participants who reported recurrent falls (2 or more falls per year)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cocoa extract + multivitamin
Dietary supplement: Multivitamin
Multivitamin
Dietary supplement: Cocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Active Comparator: Cocoa extract + multivitamin placebo
Dietary supplement: Multivitamin placebo
Multivitamin placebo
Dietary supplement: Cocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Active Comparator: Cocoa extract placebo + multivitamin
Dietary supplement: Multivitamin
Multivitamin
Dietary supplement: Cocoa extract placebo
Cocoa extract placebo
Placebo Comparator: Cocoa extract placebo + multivitamin placebo
Dietary supplement: Multivitamin placebo
Multivitamin placebo
Dietary supplement: Cocoa extract placebo
Cocoa extract placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)
Time Frame: 5 years
5 years
Recurrent falls (2 or more falls per year)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Meryl S LeBoff, MD, Brigham and Women's Hospital
  • Principal Investigator: Carolyn Crandall, MD, MS, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P003714
  • 2021A008958 (Other Identifier: MGB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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