Diet and Migraine Study



Status:Terminated
Conditions:Migraine Headaches, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:19 - 49
Updated:4/21/2016
Start Date:July 2012
End Date:May 2015

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The purpose of this study is to look at two different diets (a low carbohydrate diet and a
low fat diet) for migraine prevention in overweight or obese persons with migraine. The
overall aim is to test the theory that diet will improve migraine frequency and that such
improvements will be associated with favorable changes in body weight, inflammation, and
heart health.

Obesity is a risk factor for migraine. Further, in the past decade multiple lines of
research have substantiated the presence of migraine headaches as a risk factor for CVD (eg.
stroke). Migraineurs have also been demonstrated to have abnormal insulin responses, higher
lipids and endothelial dysfunction. Limited data suggests a low fat diet may be of benefit
in reducing migraine frequency; no studies have examined the efficacy of a low carbohydrate
(ie. low glycemic) diet for migraine prevention in adults.. None of these studies examined
the effects and potential mechanisms of such diet programs on CV health, body composition,
and the inflammatory cascade in migraineurs. This 3 -month study addresses the efficacy and
potential mechanisms of two different diets, (a low carbohydrate diet and a low fat diet)
for migraine prevention in a clinical cohort of overweight or obese persons with migraine.
The overall aim is to test the hypothesis that each behavioral intervention will improve
migraine frequency and that such improvements will be associated with favorable changes in
body composition, inflammation, and CV parameters.

Hypothesis 1.1 The mean monthly migraine frequency will be decreased in those who maintain a
low-fat diet or low-carbohydrate diet for 3 months as compared to controls.

Hypothesis 1.2 Participants randomized to the diets will demonstrate favorable changes in
body composition (eg. decrease in adipose tissue volume on magnetic resonance imaging (MRI)
and body fat on DEXA), inflammatory markers (eg. decrease in adipocytokine levels), and CV
parameters (eg. improved cholesterol panel, glucose levels and markers of arterial
stiffness) as compared to controls.

Inclusion Criteria:

- overweight or obese (BMI between 25 and 42)

- women

- >18 years and < 50 years old

- Migraine meeting ICHD criteria for at least 6 months prior to screening

- headache frequency documented > 2 and < 10 headache days per month

- BP inclusion criteria are SBP <160 or DBP <100 mm Hg

Exclusion Criteria:

- hypocaloric diet (must be weight stable for prior 3 months)

- Self-report of alcohol or substance abuse in the past year or current treatment

- Type 1 or 2 diabetes
We found this trial at
1
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Baltimore, Maryland 21224
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Baltimore, MD
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