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

Mass General Brigham

Status: Active, not recruiting

Conditions: Physical Performance; Fracture; Fall

Treatments: Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin; Dietary Supplement: Multivitamin placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05232669

2021P003714

2021A008958 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 21,442 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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21,442 participants in 4 patient groups, including a placebo group

Cocoa extract + multivitamin

Active Comparator group

Treatment:

Dietary Supplement: Multivitamin

Dietary Supplement: Cocoa extract

Cocoa extract + multivitamin placebo

Active Comparator group

Treatment:

Dietary Supplement: Multivitamin placebo

Dietary Supplement: Cocoa extract

Cocoa extract placebo + multivitamin

Active Comparator group

Treatment:

Dietary Supplement: Multivitamin

Dietary Supplement: Cocoa extract placebo

Cocoa extract placebo + multivitamin placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Multivitamin placebo

Dietary Supplement: Cocoa extract placebo