Recruiting

Cocoa Extract

Sponsor:

Brigham and Women's Hospital

Code:

NCT06808230

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cocoa extract

Cocoa extract placebo

Study Details

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

Conditions

Migraine

Study ID

NCT06808230

Start date

Jun 23, 2025

Status verified date

Jun, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

Cocoa extract

Cocoa extract manufactured as 250 mg capsules

Cocoa extract placebo

Cocoa extract placebo

Primary outcome measure

  • Recruitment [ Time Frame: 15 months ]
  • Retention [ Time Frame: From run-in to end of treatment at 12 weeks ]
  • Adherence [ Time Frame: 12 week intervention period ]

Central Contacts and Locations

Central contacts

Pamela M Rist, ScD

877-517-2555bwhcoral@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Pamela M Rist, ScD

bwhcoral@mgb.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • migraine
  • cocoa extract
  • cocoa flavanol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.