A Nutritional Intervention for Migraines

Completed · Not applicable

Conditions studied: Migraines

In brief

The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.

Key facts

Study ID

NCT01547494

Run by

Physicians Committee for Responsible Medicine

People needed

16

Starts

2011-09-01

Expected to finish

2012-10-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Migraines occurring at least twice per month, on average.
• Age at least 18 years
• Ability and willingness to participate in all components of the study
• Willingness to be assigned to either the diet group or supplement group
• Migraine medications unchanged within last 6 weeks.

You may not qualify if…

• < 18 years of age
• 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
• Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
• Pregnancy
• Unstable medical or psychiatric illness
• Likely to be disruptive in group sessions (as determined by research staff)
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study

Where it is running

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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