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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05232669
Recruitment Status : Active, not recruiting
First Posted : February 10, 2022
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Meryl LeBoff, Brigham and Women's Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital) [ Time Frame: 5 years ]
  2. Recurrent falls (2 or more falls per year) [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05232669


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Meryl S LeBoff, MD Brigham and Women's Hospital
Principal Investigator: Carolyn Crandall, MD, MS University of California, Los Angeles
Additional Information:
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Responsible Party: Meryl LeBoff, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05232669    
Other Study ID Numbers: 2021P003714
2021A008958 ( Other Identifier: MGB )
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022

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