Migraines Clinical Trial
Official title:
A Nutritional Intervention for Migraines-2
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).
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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