Cocoa Extract for Migraine Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06808230
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cocoa extract — DIETARY_SUPPLEMENT
    Cocoa extract manufactured as 250 mg capsules
  • Cocoa extract placebo — DIETARY_SUPPLEMENT
    Cocoa extract placebo

Study Details

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

Key Dates

Start date
Jun 23, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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

Primary Outcome Measure

Recruitment [ Time Frame: 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Pamela M Rist, ScD
[email protected]

Find similar trials in Boston, MA

By condition
Migraine
By specialty
Neurology
By research site
Brigham and Women's Hospital· Boston, MA

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