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NCT05232669 Clinical Trial

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

Fall Clinical Trial

— COSMOS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05232669
Other study ID # 2021P003714
Secondary ID 2021A008958
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date February 2025

Study information
Verified date May 2024
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 21442
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Cocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
• Cocoa extract placebo
Cocoa extract placebo
• Multivitamin
Multivitamin
• Multivitamin placebo
Multivitamin placebo

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

LeBoff MS, Chou SH, Ratliff KA, Cook NR, Clar A, Holman B, Copeland T, Smith DC, Rist PM, Manson JE, Sesso HD, Crandall CJ. Rationale and design of an ancillary study evaluating the effects of the cocoa flavanol and/or multivitamin interventions on falls and physical performance outcomes in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). Contemp Clin Trials. 2023 Feb;125:107078. doi: 10.1016/j.cct.2023.107078. Epub 2023 Jan 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital) 5 years
Primary Recurrent falls (2 or more falls per year) 5 years
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Completed NCT04334746 - The Discriminative Ability of the Four Balance Measures for Fall History
Completed NCT03341728 - The Sensorimotor Locus of Balance Control in Elderly Gait N/A
Completed NCT05290571 - Modified Otago Exercise Program on Balance Performance N/A
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