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Active, Not Recruiting

NCT Number: NCT05232669

COcoa Supplement and Multivitamin Outcomes Study: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fall Fracture Fractures, Bone Physical Performance Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Cocoa extract

Dietary Supplement

2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Cocoa extract placebo

Dietary Supplement

Cocoa extract placebo

Multivitamin

Dietary Supplement

Multivitamin

Multivitamin placebo

Dietary Supplement

Multivitamin placebo

Primary outcomes

  1. Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)

    Time frame: 5 years

  2. Recurrent falls (2 or more falls per year)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Acronym: COSMOS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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