Diet and Migraine Study

Johns Hopkins University

Status: Terminated

Conditions: Obesity; Migraine

Treatments: Other: Low calorie low fat diet; Other: Low carbohydrate diet; Other: AHA diet recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT01859052

NIH1K23NS078345-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: Female

Ages: 19 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Obese migraineurs

Other group

Description:

Low carbohydrate diet

Treatment:

Other: Low carbohydrate diet

Other: Low calorie low fat diet

low-fat diet

Other group

Description:

Obese Migraineurs

Treatment:

Other: Low carbohydrate diet

Other: Low calorie low fat diet

Controls

Other group

Description:

Controls receiving AHA diet recommendations

Treatment:

Other: AHA diet recommendations