Diet and Migraine Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Diet and Migraine Study

Conditions
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Migraine, Obesity

Intervention / Treatment
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* Other: Low carbohydrate diet
* Other: Low calorie low fat diet
* Other: AHA diet recommendations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Obese migraineurs<br>Low carbohydrate diet | Other: Low carbohydrate diet<br>* Subjects will follow the Atkins for Life diet. They will be given the book and a study dietitian will guide them through the induction, ongoing weight loss, pre-maintenance, and lifetime maintenance phases.<br>Other: Low calorie low fat diet<br>* The diet will be a nutritionally balanced, hypocaloric diet with a deficit of 750 kcal/day as guided by TEE. The goal is to match the calorie deficit to the low-CHO diet<br>|
| Other: low-fat diet<br>Obese Migraineurs | Other: Low carbohydrate diet<br>* Subjects will follow the Atkins for Life diet. They will be given the book and a study dietitian will guide them through the induction, ongoing weight loss, pre-maintenance, and lifetime maintenance phases.<br>Other: Low calorie low fat diet<br>* The diet will be a nutritionally balanced, hypocaloric diet with a deficit of 750 kcal/day as guided by TEE. The goal is to match the calorie deficit to the low-CHO diet<br>|
| Other: Controls<br>Controls receiving AHA diet recommendations | Other: AHA diet recommendations<br>* given information in accordance with the diet and lifestyle recommendations of the American Heart Association.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in headache frequency | Change in headache frequency from baseline to 3 months | 3 months. | 
| Mean change in body composition | The mean change in body composition from the baseline phase to 3 months | 3 months | 
| The mean change in inflammatory markers | The mean change in inflammatory markers from baseline to 3 months | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients responding to treatment | Proportion of participants responding to weight loss program as measured by a 21% or more reduction in mean monthly migraine frequency | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, obesity, low fat diet, low carbohydrate diet