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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05232669

Acronym

COSMOS

Enrollment

21442

Registered

2022-02-10

Start date

2021-05-15

Completion date

2027-02-01

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Fracture, Physical Performance

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.

Interventions

DIETARY_SUPPLEMENTCocoa extract placebo

Cocoa extract placebo

DIETARY_SUPPLEMENTMultivitamin

Multivitamin

DIETARY_SUPPLEMENTMultivitamin placebo

Multivitamin placebo

DIETARY_SUPPLEMENTCocoa extract

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMeryl S LeBoff, MD

Brigham and Women's Hospital

PRINCIPAL_INVESTIGATORCarolyn Crandall, MD, MS

University of California, Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026