Cocoa Flavanols for Migraine: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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
干预措施: Cocoa extract (Dietary Supplement)
1000 mg cocoa extract
Participants assigned to this arm will take four 250 mg cocoa extract pills per day
干预措施: Cocoa extract (Dietary Supplement)
Placebo
Participants assigned to this arm will take four placebo pills per day.
干预措施: Cocoa extract placebo (Dietary Supplement)
结局指标
主要结局
Recruitment
时间窗: 15 months
We will be able to recruit and randomize 114 eligible individuals
Retention
时间窗: 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
时间窗: 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)
次要结局
- Migraine days(Four week run-in period and final four weeks of the 12 week intervention period)
- Responder rate(Four week run-in period and final four weeks of the 12 week intervention period)
- Migraine severity(Four week run-in period and final four weeks of the 12 week intervention period)
- Adverse events(12 week intervention period)
- Reports of worsening of migraine symptoms(12 week intervention period)
- Allodynia Symptom Checklist(Baseline and end of the 12 week intervention period)
- Headache Related Disability (HIT-6)(Baseline and end of the 12 week intervention period)
- PROMIS-29(Baseline and end of the 12 week intervention period)
- Urine levels of gamma-valerolactone metabolites (gVLM)(Four week run-in period and final four weeks of the 12 week intervention period)
研究者
Pamela M. Rist, ScD
Associate Epidemiologist
Brigham and Women's Hospital