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

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

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.

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)