A Nutritional Intervention for Migraines-2

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.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Key facts

Study ID

NCT01699009

Run by

Physicians Committee for Responsible Medicine

People needed

24

Starts

2012-10-01

Expected to finish

2014-05-01

Last updated by the study team

2015-10-20

Who can join

Age: 18 and older, up to 100. 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 Disorders:
• 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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