MigraineCORALNCT06808230
Cocoa Extract for Migraine Trial
A study testing Cocoa extract in people with Migraine, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Cocoa extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pamela M Rist, ScD, bwhcoral@mgb.org
About this study
Official title: Cocoa Flavanols for Migraine: A Pilot Study
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
- Being tested
- Cocoa extract, Cocoa extract placebo
- Keywords
- migraine, cocoa extract, cocoa flavanol
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa extractDietary supplement
Cocoa extract manufactured as 250 mg capsules
Cocoa extract placeboDietary supplement
Cocoa extract placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants assigned to this arm will take four placebo pills per day. Receives: Dietary Supplement: Cocoa extract placebo |
| 500 mg cocoa extract | Experimental | Participants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day Receives: Dietary Supplement: Cocoa extract |
| 1000 mg cocoa extract | Experimental | Participants assigned to this arm will take four 250 mg cocoa extract pills per day Receives: Dietary Supplement: Cocoa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
We will be able to recruit and randomize 114 eligible individuals
Measured: 15 months
Retention
Retention will be quantified by the proportion of subjects who record their migraines for at least 22 out of 28 days during run-in and the last four weeks of the intervention and complete all questionnaires at baseline and follow-up
Measured: From run-in to end of treatment at 12 weeks
Adherence
Adherence will be calculated as the proportion of participants who miss no more than 12 days of study pills (i.e. participants will consume study pills on 85% of the intervention days)
Measured: 12 week intervention period
Secondary outcomes (9)
Migraine days
Number of migraine attacks as recorded in migraine diaries
Measured: Four week run-in period and final four weeks of the 12 week intervention period
Responder rate
Proportion of individuals who experience a ≥50% reduction in migraine days
Measured: Four week run-in period and final four weeks of the 12 week intervention period
Migraine severity
Four-point scale with categories of "absent, mild, moderate, or severe".
Measured: Four week run-in period and final four weeks of the 12 week intervention period
Adverse events
Potential side effects and adverse events
Measured: 12 week intervention period
Reports of worsening of migraine symptoms
Worsening of photophobia, phonophobia, or osmophobia, and worsening of aura symptoms in the past week compared to the week prior
Measured: 12 week intervention period
Allodynia Symptom Checklist
Survey assessing how often individuals with migraine experience allodynia
Measured: Baseline and end of the 12 week intervention period
Migraine Disability Assessment Test (MIDAS)
Evaluates the impact headaches have on a patient's life
Measured: Baseline and end of the 12 week intervention period
PROMIS-29
Measures of patient-reported health status for physical, mental, and social well-being
Measured: Baseline and end of the 12 week intervention period
Urine levels of gamma-valerolactone metabolites (gVLM)
Biomarker of dietary flavanol intake
Measured: Four week run-in period and final four weeks of the 12 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start23 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Pamela M. Rist, ScD, Brigham and Women's Hospital
- Investigators
- Pamela M Rist, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808230
- Sponsor's protocol ID
- 2024P003655
- Other IDs
- U01AT012611
- Acronym
- CORAL
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocoa Flavanols for Migraine: A Pilot Study
- ClinicalTrials.gov ID
- NCT06808230
- Acronym / sponsor ID
- CORAL / 2024P003655
- Conditions
- Migraine
- Keywords
- migraine, cocoa extract, cocoa flavanol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Cocoa extract placeboParticipants assigned to this arm will take four placebo pills per day. |
| 500 mg cocoa extract | Experimental | Dietary Supplement: Cocoa extractParticipants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day |
| 1000 mg cocoa extract | Experimental | Dietary Supplement: Cocoa extractParticipants assigned to this arm will take four 250 mg cocoa extract pills per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa extractCocoa extract manufactured as 250 mg capsules | Dietary supplement | 1000 mg cocoa extract, 500 mg cocoa extract |
| Cocoa extract placeboCocoa extract placebo | Dietary supplement | Placebo |
Primary outcome
Recruitment
Time frame: 15 months
We will be able to recruit and randomize 114 eligible individuals
Retention
Time frame: From run-in to end of treatment at 12 weeks
Retention will be quantified by the proportion of subjects who record their migraines for at least 22 out of 28 days during run-in and the last four weeks of the intervention and complete all questionnaires at baseline and follow-up
Adherence
Time frame: 12 week intervention period
Adherence will be calculated as the proportion of participants who miss no more than 12 days of study pills (i.e. participants will consume study pills on 85% of the intervention days)
9 secondary outcomes
Migraine days
Time frame: Four week run-in period and final four weeks of the 12 week intervention period
Responder rate
Time frame: Four week run-in period and final four weeks of the 12 week intervention period
Migraine severity
Time frame: Four week run-in period and final four weeks of the 12 week intervention period
Adverse events
Time frame: 12 week intervention period
Reports of worsening of migraine symptoms
Time frame: 12 week intervention period
Allodynia Symptom Checklist
Time frame: Baseline and end of the 12 week intervention period
Migraine Disability Assessment Test (MIDAS)
Time frame: Baseline and end of the 12 week intervention period
PROMIS-29
Time frame: Baseline and end of the 12 week intervention period
Urine levels of gamma-valerolactone metabolites (gVLM)
Time frame: Four week run-in period and final four weeks of the 12 week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela M Rist, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa extract in people with Migraine, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela M Rist, ScD (877-517-2555, bwhcoral@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.