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Chocolate pill and multivitamin put to the test against heart disease and cancer

NCT ID NCT02422745

Prevention Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This large study tested whether taking daily cocoa extract (a source of flavanols) or a standard multivitamin could lower the risk of heart disease and cancer in over 21,000 older adults. Participants took the supplements or placebos for several years, and researchers tracked heart attacks, strokes, and cancer diagnoses. The goal was to see if these common supplements could be a simple way to prevent major diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cocoa extract and multivitamin
What this could lead to
If effective, this could point toward a simple, daily supplement to help prevent heart disease and cancer in older adults.
What could go wrong
This is a large completed trial, but supplements often show mixed results; benefits may be small or absent, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

21,442 people

The number who actually took part.

Started

Jun 2015

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Women ≥ 65 years of age participating in the Women's Health Initiative (WHI) Extension Study. 2. Men ≥ 60 years of age and women age ≥ 65 years of age who were contacted for but not randomized into the VITAL trial. 3. Other women ≥ 65 years of age and men aged ≥ 60 years of age who responded to targeted mass mailings and volunteers who learned about the trial through the media or through ResearchMatch.org, an electronic recruitment website. 4. Willing to participate, as evidenced by providing informed consent and completing all required baseline forms. Exclusion Criteria: 1. History of myocardial infarction or stroke. 2. Diagnosed with invasive cancer other than non-melanoma skin cancer in the last 2 years prior to enrollment. 3. Any serious illness that would preclude participation and/or completion of the trial, including the diagnosis of kidney failure and current dialysis treatment. 4. Taking cocoa extract or multivitamin supplements and not willing to forego use during the trial. 5. Taking total supplemental vitamin D \> 1,000 IU/day and not willing to forego use during the trial. 6. Taking total supplemental calcium \> 1,200 mg/day and not willing to forego use during the trial. 7. Extreme sensitivity to caffeine. 8. Consume \< 75% of the expected number of both types of supplements during the run-in phase. 9. Unable to communicate in English due to language barrier or mental incapacity.

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Conditions

The condition(s) this trial relates to.

neoplasm cancer prevention target cardiovascular disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Cardiovascular disease

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

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