Diet and Migraine Study

NCT ID: NCT01859052

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-05-31

Brief Summary

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

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.

Conditions

Migraine; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Obese migraineurs

Low carbohydrate diet

Group Type: OTHER

Low carbohydrate diet

Intervention Type: 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.

Low calorie low fat diet

Intervention Type: 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

low-fat diet

Obese Migraineurs

Group Type: OTHER

Low carbohydrate diet

Intervention Type: 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.

Low calorie low fat diet

Intervention Type: 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

Controls

Controls receiving AHA diet recommendations

Group Type: OTHER

AHA diet recommendations

Intervention Type: OTHER

given information in accordance with the diet and lifestyle recommendations of the American Heart Association.

Interventions

Low carbohydrate diet

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.

Intervention Type: OTHER

Low calorie low fat diet

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

Intervention Type: OTHER

AHA diet recommendations

given information in accordance with the diet and lifestyle recommendations of the American Heart Association.

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Drs Barbara Peterlin

Director of Headache Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara L Peterlin, DO

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NIH1K23NS078345-01

Identifier Type: -

Identifier Source: org_study_id