Obesity Clinical Trial - Diet & Migraine Study

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01859052
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Terminated
Phase	N/A
Start date	July 2012
Completion date	May 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diet and Migraine Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms