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Cocoa Extract for Migraine Trial

Cocoa Flavanols for Migraine: A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Pills, Urine samples, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The main questions it aims to answer are: * Will we be able to enroll 114 participants during the recruitment period? * Will participants take study pills daily during the pill-taking period?"
  • "Participants will be asked to: * Provide two urine samples * Complete daily questionnaires * Take four study pills a day for 12 weeks"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adults with migraines can be enrolled and take cocoa extract pills each day. It compares two doses with a placebo, a pill with no cocoa extract, to see how acceptable the doses are. Participants take four pills a day for 12 weeks, give two urine samples, and fill out daily surveys.

The goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are: * Will we be able to enroll 114 participants during the recruitment period? * Will participants take study pills daily during the pill-taking period? Researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population. Participants will be asked to: * Provide two urine samples * Complete daily questionnaires * Take four study pills a day for 12 weeks

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have had migraines for at least one year, diagnosed by a clinician and checked with a study screening tool. Migraines must not meet the rules for chronic migraine.
  • Have had 4 to 14 migraine attacks in the 30 days before joining.
  • During the 28-day study lead-in, fill out a headache diary on at least 22 days and report 4 to 14 days with migraines.
  • If taking medicine to prevent or treat migraines, have started no new migraine medicine in the past 3 months.
  • Have started no new behavioral treatments in the past 3 months and/or agree not to start them during the study.
  • Be willing to do all study tasks and be assigned by chance to any study group.
  • Be fluent in English, own an iPhone or Android device, and be willing to download the MyCap app.

Who can't join

  • Have a history of stroke, a mini-stroke, brain or spine surgery, or a brain injury; are being treated for a concussion; or have cluster headaches, a brain tumor, a bulging brain blood vessel, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder.
  • Have kidney failure, receive dialysis (treatment that filters blood), or believe a health problem would make study tasks hard to follow.
  • Currently misuse alcohol or drugs.
  • Have a clinician's diagnosis of headaches caused by using headache medicine too often.
  • Receive Botox for migraines now or have received it in the past 6 months.
  • Do not return the starting urine sample.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are unwilling to stop cocoa extract supplements outside the study, or are extremely sensitive to caffeine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MA