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Clinical Trials/NCT05232669
NCT05232669Active, not recruitingNot Applicable

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

Brigham and Women's Hospital1 site in 1 country21,442 target enrollmentStarted: May 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
21,442
Locations
1
Primary Endpoint
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Not provided

Arms & Interventions

Cocoa extract + multivitamin

Active Comparator

Intervention: Multivitamin (Dietary Supplement)

Cocoa extract + multivitamin placebo

Active Comparator

Intervention: Multivitamin placebo (Dietary Supplement)

Cocoa extract placebo + multivitamin

Active Comparator

Intervention: Cocoa extract placebo (Dietary Supplement)

Cocoa extract placebo + multivitamin

Active Comparator

Intervention: Multivitamin (Dietary Supplement)

Cocoa extract placebo + multivitamin placebo

Placebo Comparator

Intervention: Cocoa extract placebo (Dietary Supplement)

Cocoa extract placebo + multivitamin placebo

Placebo Comparator

Intervention: Multivitamin placebo (Dietary Supplement)

Cocoa extract + multivitamin

Active Comparator

Intervention: Cocoa extract (Dietary Supplement)

Cocoa extract + multivitamin placebo

Active Comparator

Intervention: Cocoa extract (Dietary Supplement)

Outcomes

Primary Outcomes

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

Time Frame: 5 years

Recurrent falls (2 or more falls per year)

Time Frame: 5 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meryl LeBoff

Principal Investigator

Brigham and Women's Hospital

Study Sites (1)

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