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| ID | Type | Description | Link |
|---|---|---|---|
| U01AT012611 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants assigned to this arm will take four placebo pills per day. |
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| 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 |
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| 1000 mg cocoa extract | Experimental | Participants assigned to this arm will take four 250 mg cocoa extract pills per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa extract | Dietary Supplement | Cocoa extract manufactured as 250 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | We will be able to recruit and randomize 114 eligible individuals | 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 | 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) | 12 week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine days | Number of migraine attacks as recorded in migraine diaries | 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 |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pamela M Rist, ScD | Contact | 877-517-2555 | bwhcoral@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Pamela M Rist, ScD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
Cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data
Data will be shared no later than time of the final publication of study results or the end of the performance period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
Data and supporting materials will be shared on the Harvard Dataverse. The data that is shared will be shared by unrestricted download.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Cocoa extract placebo | Dietary Supplement | Cocoa extract placebo |
|
| 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". | Four week run-in period and final four weeks of the 12 week intervention period |
| Adverse events | Potential side effects and adverse events | 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 | 12 week intervention period |
| Allodynia Symptom Checklist | Survey assessing how often individuals with migraine experience allodynia | Baseline and end of the 12 week intervention period |
| Headache Related Disability (HIT-6) | Evaluates the impact headaches have on a patient's life and | Baseline and end of the 12 week intervention period |
| PROMIS-29 | Measures of patient-reported health status for physical, mental, and social well-being | Baseline and end of the 12 week intervention period |
| Urine levels of gamma-valerolactone metabolites (gVLM) | Biomarker of dietary flavanol intake | Four week run-in period and final four weeks of the 12 week intervention period |
| D009422 | Nervous System Diseases |