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COMPLETED
NCT02422745
PHASE4

COcoa Supplement and Multivitamin Outcomes Study

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether taking daily, dietary supplements of cocoa extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard multivitamin reduces the risk of developing cardiovascular disease (including heart attack, stroke, coronary revascularization, unstable angina or acute coronary syndrome (ACS) requiring hospitalization, carotid artery surgery, and peripheral artery surgery or angioplasty, and cardiovascular mortality) and cancer.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21442

Start Date

2015-06

Completion Date

2023-06-05

Last Updated

2026-07-13

Healthy Volunteers

Yes

Interventions

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

DIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo

DIETARY_SUPPLEMENT

Multivitamin placebo

Multivitamin placebo

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States