Migraine
Conditions
Keywords
migraine, cocoa extract, cocoa flavanol
Brief 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
Interventions
DIETARY_SUPPLEMENTCocoa extract
Cocoa extract manufactured as 250 mg capsules
DIETARY_SUPPLEMENTCocoa extract placebo
Cocoa extract placebo
Sponsors
Brigham and Women's Hospital
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 15 months | We will be able to recruit and randomize 114 eligible individuals |
| Retention | From 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 |
| Adherence | 12 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine days | Four week run-in period and final four weeks of the 12 week intervention period | Number of migraine attacks as recorded in migraine diaries |
| Responder rate | Four week run-in period and final four weeks of the 12 week intervention period | Proportion of individuals who experience a ≥50% reduction in migraine days |
| Migraine severity | Four week run-in period and final four weeks of the 12 week intervention period | Four-point scale with categories of "absent, mild, moderate, or severe". |
| Adverse events | 12 week intervention period | Potential side effects and adverse events |
| Reports of worsening of migraine symptoms | 12 week intervention period | Worsening of photophobia, phonophobia, or osmophobia, and worsening of aura symptoms in the past week compared to the week prior |
| Allodynia Symptom Checklist | Baseline and end of the 12 week intervention period | Survey assessing how often individuals with migraine experience allodynia |
| Headache Related Disability (HIT-6) | Baseline and end of the 12 week intervention period | Evaluates the impact headaches have on a patient's life and |
| PROMIS-29 | Baseline and end of the 12 week intervention period | Measures of patient-reported health status for physical, mental, and social well-being |
| Urine levels of gamma-valerolactone metabolites (gVLM) | Four week run-in period and final four weeks of the 12 week intervention period | Biomarker of dietary flavanol intake |
Countries
United States
Contacts
CONTACTPamela M Rist, ScD
PRINCIPAL_INVESTIGATORPamela M Rist, ScD
Brigham and Women's Hospital
Outcome results
None listed