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COcoa Supplement and Multivitamin Outcomes Study

NCT02422745 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21442

Last updated 2025-09-24

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Mars, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • JoAnn E. Manson, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2022-07-31
Completion
2023-06-05

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02422745 on ClinicalTrials.gov