Cocoa Extract for Migraine Trial (CORAL)

Mass General Brigham

Status: Enrolling

Conditions: Migraine

Treatments: Dietary Supplement: Cocoa extract; Dietary Supplement: Cocoa extract placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06808230

U01AT012611 (U.S. NIH Grant/Contract)

2024P003655

Details and patient eligibility

About

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

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants assigned to this arm will take four placebo pills per day.

Treatment:

Dietary Supplement: Cocoa extract placebo

500 mg cocoa extract

Experimental group

Description:

Participants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day

Treatment:

Dietary Supplement: Cocoa extract

1000 mg cocoa extract

Experimental group

Description:

Participants assigned to this arm will take four 250 mg cocoa extract pills per day

Treatment:

Dietary Supplement: Cocoa extract