CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21,442 enrolled
Drug / intervention
Cocoa extract +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02422745
NCT02422745Phase 4Completed

COcoa Supplement and Multivitamin Outcomes Study

Brigham and Women's Hospital·interventional·Posted Apr 21, 2015·Updated Sep 24, 2025

In Brief

A Phase 4 clinical trial evaluating Cocoa extract, Multivitamin, and 2 other interventions for Cardiovascular Disease and Cancer. Completed, enrolled 21,442 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 21, 2015
Enrollment StartJun 1, 2015
Primary CompletionJul 1, 2022
Study CompletionJun 5, 2023
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 11.2 years ago

Interventions

Cocoa extractdietary

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

Multivitamindietary

Multivitamin

Cocoa extract placebodietary

Cocoa extract placebo

Multivitamin placebodietary

Multivitamin placebo