Cocoa Extract for Migraine Trial
Purpose
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
Condition
- Migraine
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Participants assigned to this arm will take four placebo pills per day. |
|
|
Experimental 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 |
|
|
Experimental 1000 mg cocoa extract |
Participants assigned to this arm will take four 250 mg cocoa extract pills per day |
|
Recruiting Locations
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital