Cocoa Flavanols for Migraine: A Pilot Study
Brigham and Women's Hospital
Summary
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 conf…
Interventions
- Dietary SupplementCocoa extract
Cocoa extract manufactured as 250 mg capsules
- Dietary SupplementCocoa extract placebo
Cocoa extract placebo
Location
- Brigham and Women's HospitalBoston, Massachusetts