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Cocoa Extract for Migraine Trial

NCT06808230 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Cocoa extract

Cocoa extract manufactured as 250 mg capsules

DIETARY_SUPPLEMENT

Cocoa extract placebo

Cocoa extract placebo

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06808230 on ClinicalTrials.gov