COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Brigham and Women's Hospital
- 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
Intervention: Multivitamin (Dietary Supplement)
Cocoa extract + multivitamin placebo
Intervention: Multivitamin placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin
Intervention: Cocoa extract placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin
Intervention: Multivitamin (Dietary Supplement)
Cocoa extract placebo + multivitamin placebo
Intervention: Cocoa extract placebo (Dietary Supplement)
Cocoa extract placebo + multivitamin placebo
Intervention: Multivitamin placebo (Dietary Supplement)
Cocoa extract + multivitamin
Intervention: Cocoa extract (Dietary Supplement)
Cocoa extract + multivitamin placebo
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
Meryl LeBoff
Principal Investigator
Brigham and Women's Hospital