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Study team was unable to effectively conduct the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese migraineurs | Other | Low carbohydrate diet |
|
| low-fat diet | Other | Obese Migraineurs |
|
| Controls | Other | Controls receiving AHA diet recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate diet | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara L Peterlin, DO | The Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Bayview Headache Center | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low calorie low fat diet | Other | 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 |
|
| AHA diet recommendations | Other | given information in accordance with the diet and lifestyle recommendations of the American Heart Association. |
|
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |