Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01547494
Eligibility Criteria:
Inclusion Criteria:
1. A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders18
* At least 5 attacks fulfilling criteria the criteria below
* Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
* Headache has at least two of the following characteristics:
* unilateral location
* pulsating quality
* moderate or severe pain intensity
* aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
* During headache at least one of the following:
* nausea and/or vomiting
* photophobia and phonophobia
* Not attributed to another disorder
2. Migraines occurring at least twice per month, on average.
3. Age at least 18 years
4. Ability and willingness to participate in all components of the study
5. Willingness to be assigned to either the diet group or supplement group
6. Migraine medications unchanged within last 6 weeks.
Exclusion Criteria:
1. \< 18 years of age
2. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
3. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
4. Pregnancy
5. Unstable medical or psychiatric illness
6. Likely to be disruptive in group sessions (as determined by research staff)
7. Already following a low-fat, vegan diet
8. Lack of English fluency
9. Inability to maintain current medication regimen
10. Inability or unwillingness to participate in all components of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01547494
Study Brief:
Protocol Section:
NCT01547494