RECRUITING

Cocoa Extract for Migraine Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Cocoa Flavanols for Migraine: A Pilot Study

Quick Facts

Study Start:2025-06-23
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06808230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women and men aged ≥18 years
  2. * 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)
  3. * 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.
  4. * History of migraine dating for at least one year
  5. * Self-report of 4 to 14 migraine attacks during the 30 days prior to enrollment in the study
  6. * Completion of at least 22 headache diary days during the 28 day run-in period
  7. * If currently using medications to prevent or treat migraine, no new medication use within the past 3 months
  8. * No new use of behavioral interventions within the past 3 months and/or agree to not begin new behavioral interventions during this trial
  9. * Be willing to complete all study procedures and be randomized to all interventional groups
  10. * Be fluent in English
  11. * Own an iPhone or Android device and be willing to download MyCap to the device
  1. * 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
  2. * Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol
  3. * Current alcohol or substance abuse (self-reported)
  4. * Self-reported clinician diagnosis of medication overuse headache
  5. * Currently or recently (past 6 months) received Botox treatment for migraine
  6. * Failure to return the baseline urine sample
  7. * Currently pregnant, nursing, or intending to become pregnant during the study period.
  8. * Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial
  9. * Extreme sensitivity to caffeine

Contacts and Locations

Study Contact

Pamela M Rist, ScD
CONTACT
877-517-2555
bwhcoral@mgb.org

Principal Investigator

Pamela M Rist, ScD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Pamela M Rist, ScD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-23
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • migraine
  • cocoa extract
  • cocoa flavanol

Additional Relevant MeSH Terms

  • Migraine