Cocoa Extract for Migraine Trial

Brigham and Women's Hospital114 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

114

Conditions

Migraine

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recruitment

We will be able to recruit and randomize 114 eligible individuals

Time frame: 15 months

Retention

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

Time frame: From run-in to end of treatment at 12 weeks

Adherence

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)

Time frame: 12 week intervention period

Secondary Outcomes

Migraine days

Number of migraine attacks as recorded in migraine diaries

Time frame: Four week run-in period and final four weeks of the 12 week intervention period

Responder rate

Proportion of individuals who experience a ≥50% reduction in migraine days

Time frame: Four week run-in period and final four weeks of the 12 week intervention period

Migraine severity

Four-point scale with categories of "absent, mild, moderate, or severe".

Time frame: Four week run-in period and final four weeks of the 12 week intervention period

Adverse events

Potential side effects and adverse events

Time frame: 12 week intervention period

Reports of worsening of migraine symptoms

Worsening of photophobia, phonophobia, or osmophobia, and worsening of aura symptoms in the past week compared to the week prior

Time frame: 12 week intervention period

Allodynia Symptom Checklist

Survey assessing how often individuals with migraine experience allodynia

Time frame: Baseline and end of the 12 week intervention period

Headache Related Disability (HIT-6)

Evaluates the impact headaches have on a patient's life and

Time frame: Baseline and end of the 12 week intervention period

PROMIS-29

Measures of patient-reported health status for physical, mental, and social well-being

Time frame: Baseline and end of the 12 week intervention period

Urine levels of gamma-valerolactone metabolites (gVLM)

Biomarker of dietary flavanol intake

Time frame: Four week run-in period and final four weeks of the 12 week intervention period

Cocoa Extract for Migraine Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts