NCT06808230

Cocoa Extract for Migraine Trial

Cocoa Flavanols for Migraine: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cocoa extract	Cocoa extract manufactured as 250 mg capsules
DIETARY_SUPPLEMENT	Cocoa extract placebo	Cocoa extract placebo

Timeline

• Start date: 2025-06-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-02-05
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States