COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance
NCT ID: NCT05232669
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
21442 participants
INTERVENTIONAL
2021-05-15
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Cocoa extract + multivitamin
Cocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Multivitamin
Multivitamin
Cocoa extract + multivitamin placebo
Cocoa extract
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Multivitamin placebo
Multivitamin placebo
Cocoa extract placebo + multivitamin
Cocoa extract placebo
Cocoa extract placebo
Multivitamin
Multivitamin
Cocoa extract placebo + multivitamin placebo
Cocoa extract placebo
Cocoa extract placebo
Multivitamin placebo
Multivitamin placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Participants who reported recurrent falls (2 or more falls per year)
60 Years
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Meryl LeBoff
Principal Investigator
Principal Investigators
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Meryl S LeBoff, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Carolyn Crandall, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Related Links
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COSMOS Trial Website
Other Identifiers
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2021A008958
Identifier Type: OTHER
Identifier Source: secondary_id
2021P003714
Identifier Type: -
Identifier Source: org_study_id
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