A Nutritional Intervention for Migraines-2

Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
supplements can help reduce pain and also reduce the need for pain medications for some
people. The investigators will ask about 100 people to participate. All of them will get a
low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
placebo), although some will get the diet first, and others will get the supplement first.
This order in which they will get the diet and the supplement will be determined randomly,
that is, by chance (like the toss of a coin). The principal measures are pain as measured by
Visual Analog Scale (VAS)and the change in migraines frequency.

Mood change will be measured using the Center for Epidemiologic Studies Depression
Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Inclusion Criteria:

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.

Exclusion Criteria:

- < 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