Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
114 participants
INTERVENTIONAL
2025-06-23
2026-12-01
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Placebo
Participants assigned to this arm will take four placebo pills per day.
Cocoa extract placebo
Cocoa extract placebo
500 mg cocoa extract
Participants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day
Cocoa extract
Cocoa extract manufactured as 250 mg capsules
1000 mg cocoa extract
Participants assigned to this arm will take four 250 mg cocoa extract pills per day
Cocoa extract
Cocoa extract manufactured as 250 mg capsules
Interventions
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Cocoa extract
Cocoa extract manufactured as 250 mg capsules
Cocoa extract placebo
Cocoa extract placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Pamela M. Rist, ScD
Associate Epidemiologist
Principal Investigators
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Pamela M Rist, ScD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024P003655
Identifier Type: -
Identifier Source: org_study_id
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