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

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.

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

Conditions
-----------------
Fall, Physical Performance, Fracture

Intervention / Treatment
-----------------
* Dietary Supplement: Cocoa extract
* Dietary Supplement: Cocoa extract placebo
* Dietary Supplement: Multivitamin
* Dietary Supplement: Multivitamin placebo


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cocoa extract + multivitamin<br> | Dietary Supplement: Cocoa extract<br>* 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine<br>Dietary Supplement: Multivitamin<br>* Multivitamin<br>|
| Active Comparator: Cocoa extract + multivitamin placebo<br> | Dietary Supplement: Cocoa extract<br>* 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine<br>Dietary Supplement: Multivitamin placebo<br>* Multivitamin placebo<br>|
| Active Comparator: Cocoa extract placebo + multivitamin<br> | Dietary Supplement: Cocoa extract placebo<br>* Cocoa extract placebo<br>Dietary Supplement: Multivitamin<br>* Multivitamin<br>|
| Placebo Comparator: Cocoa extract placebo + multivitamin placebo<br> | Dietary Supplement: Cocoa extract placebo<br>* Cocoa extract placebo<br>Dietary Supplement: Multivitamin placebo<br>* Multivitamin placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital) |  | 5 years | 
| Recurrent falls (2 or more falls per year) |  | 5 years |