NCT05232669

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,442

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2021Feb 2027

Study Start

First participant enrolled

May 15, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

January 31, 2022

Last Update Submit

April 10, 2026

Conditions

FallPhysical PerformanceFracture

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Cocoa extract + multivitamin

ACTIVE COMPARATOR
Dietary Supplement: Cocoa extractDietary Supplement: Multivitamin

Cocoa extract + multivitamin placebo

ACTIVE COMPARATOR
Dietary Supplement: Cocoa extractDietary Supplement: Multivitamin placebo

Cocoa extract placebo + multivitamin

ACTIVE COMPARATOR
Dietary Supplement: Cocoa extract placeboDietary Supplement: Multivitamin

Cocoa extract placebo + multivitamin placebo

PLACEBO COMPARATOR
Dietary Supplement: Cocoa extract placeboDietary Supplement: Multivitamin placebo

Interventions

Cocoa extract placeboDIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo + multivitaminCocoa extract placebo + multivitamin placebo
MultivitaminDIETARY_SUPPLEMENT

Multivitamin

Cocoa extract + multivitaminCocoa extract placebo + multivitamin
Multivitamin placeboDIETARY_SUPPLEMENT

Multivitamin placebo

Cocoa extract + multivitamin placeboCocoa extract placebo + multivitamin placebo
Cocoa extractDIETARY_SUPPLEMENT

2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine

Cocoa extract + multivitaminCocoa extract + multivitamin placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • LeBoff MS, Chou SH, Ratliff KA, Cook NR, Clar A, Holman B, Copeland T, Smith DC, Rist PM, Manson JE, Sesso HD, Crandall CJ. Rationale and design of an ancillary study evaluating the effects of the cocoa flavanol and/or multivitamin interventions on falls and physical performance outcomes in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). Contemp Clin Trials. 2023 Feb;125:107078. doi: 10.1016/j.cct.2023.107078. Epub 2023 Jan 6.

    PMID: 36621596BACKGROUND

Related Links

MeSH Terms

Conditions

Fractures, Bone

Interventions

ChocolateGeritol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Meryl S LeBoff, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Carolyn Crandall, MD, MS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

May 15, 2021

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)