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Cocoa Extract for Migraine Trial

This study is looking into whether a cocoa extract supplement can help people with episodic migraine. Researchers want to see if they can successfully recruit 114 participants and if those participants will take the study pills daily. You might be able to join if you are 18 or older and have a doctor's diagnosis of migraine that isn't chronic. The study will compare different doses of cocoa extract to a placebo (an inactive substance) to understand how well people tolerate and stick with taking the supplement.

Study design
This study plans to enroll 114 participants. It will compare two doses of cocoa extract to a placebo.
What's involved
You would be asked to provide two urine samples, complete daily questionnaires, and take four study pills a day for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures retention from the run-in period to the end of treatment at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06808230

Cocoa Extract for Migraine Trial

Recruiting
NAAges 18+Interventional
Brigham and Women's Hospital
~114 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Cocoa extractCocoa extract placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment
Measured over 15 months
+2 more outcomes measured

Conditions

Migraine

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Pamela M Rist, ScD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Pamela M Rist, ScD
[email protected]
877-517-2555
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Recruitment15 months

    We will be able to recruit and randomize 114 eligible individuals

  • RetentionFrom run-in to end of treatment at 12 weeks

    Retention will be quantified by the proportion of subjects who record their migraines for at least 22 out of 28 days during run-in and the last four weeks of the intervention and complete all questionnaires at baseline and follow-up

  • Adherence12 week intervention period

    Adherence will be calculated as the proportion of participants who miss no more than 12 days of study pills (i.e. participants will consume study pills on 85% of the intervention days)