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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05232669
• Collaborator: (none)
• Enrollment: 21,442
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 44.6
• Patients Per Site Per Month: 480.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fall; Physical Performance; Fracture	Dietary Supplement: Cocoa extract; Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Multivitamin; Dietary Supplement: Multivitamin placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21442 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance
• Actual Study Start Date: May 15, 2021
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital) [5 years]

2. Recurrent falls (2 or more falls per year) [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Meryl S LeBoff, MD, Brigham and Women's Hospital
• Principal Investigator: Carolyn Crandall, MD, MS, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• COSMOS Trial Website

Publications

None provided.

• Responsible Party: Meryl LeBoff, Principal Investigator, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT05232669
• Other Study ID Numbers: 2021P003714; 2021A008958
• First Posted: Feb 10, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 18, 2022