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Could cocoa extract help tame migraines? scientists launch pilot study

NCT ID NCT06808230

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This pilot study explores whether taking high-dose cocoa extract supplements is feasible and acceptable for people with episodic migraine. Researchers will compare two doses of cocoa extract to a placebo, tracking how many participants stick with the daily pills for 12 weeks. The study also collects data on migraine days and severity, but its main goal is to see if a larger trial is possible.

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 (dietary supplement)
What this could lead to
If successful, this could pave the way for larger trials testing cocoa flavanols as a potential dietary approach to reduce migraine frequency.
What could go wrong
This is a small pilot study focused on feasibility, not on proving effectiveness. It may not show any benefit for migraines, and high doses could cause side effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women and men aged ≥18 years * Self-reported clinician diagnosis of migraine with or without aura which does not meet criteria for chronic migraine (according to the International Classification of Headache Disorders 3rd edition) * Individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable migraine by the American Migraine Study (AMS) migraine screener. The AMS migraine screener, which has a sensitivity of 100% and a specificity of 82% for the diagnosis of migraine will be used to confirm self-reported migraine status. * History of migraine dating for at least one year * Self-report of 4 to 14 migraine attacks during the 30 days prior to enrollment in the study * Completion of at least 22 headache diary days during the 28 day run-in period o Report migraine frequency between 4 to 14 days during the 28 day run-in period * If currently using medications to prevent or treat migraine, no new medication use within the past 3 months * No new use of behavioral interventions within the past 3 months and/or agree to not begin new behavioral interventions during this trial * Be willing to complete all study procedures and be randomized to all interventional groups * Be fluent in English * Own an iPhone or Android device and be willing to download MyCap to the device Exclusion Criteria: * Self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a concussion; and self-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder * Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol * Current alcohol or substance abuse (self-reported) * Self-reported clinician diagnosis of medication overuse headache * Currently or recently (past 6 months) received Botox treatment for migraine * Failure to return the baseline urine sample * Currently pregnant, nursing, or intending to become pregnant during the study period. * Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial * Extreme sensitivity to caffeine

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

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

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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