Diet and Migraine Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Drs Barbara Peterlin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01859052
First received: May 10, 2013
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Migraine
Obesity
Other: Low carbohydrate diet
Other: Low calorie low fat diet
Other: AHA diet recommendations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diet and Migraine Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mean change in headache frequency [ Time Frame: 3 months. ] [ Designated as safety issue: No ]
    Change in headache frequency from baseline to 3 months

  • Mean change in body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The mean change in body composition from the baseline phase to 3 months

  • The mean change in inflammatory markers [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    The mean change in inflammatory markers from baseline to 3 months


Secondary Outcome Measures:
  • Proportion of patients responding to treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of participants responding to weight loss program as measured by a 21% or more reduction in mean monthly migraine frequency


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Obese migraineurs
Low carbohydrate diet
Other: 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.
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
low-fat diet
Obese Migraineurs
Other: 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.
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
Controls
Controls receiving AHA diet recommendations
Other: AHA diet recommendations
given information in accordance with the diet and lifestyle recommendations of the American Heart Association.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859052

Contacts
Contact: Linda White, MS,CRNP 410-550-4418 lwhite@jhmi.edu
Contact: Meredith Dobrosielski mdobros1@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Bayview Headache Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Barbara L Peterlin, D.O.    215-410-2794    lpeterlin@jhmi.edu   
Contact: Linda White, MS,CRNP    410-550-4418    lwhite@jhmi.edu   
Principal Investigator: Barbara L Peterlin, DO         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Barbara L Peterlin, DO The Johns Hopkins University
  More Information

No publications provided

Responsible Party: Drs Barbara Peterlin, Director of Headache Research, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01859052     History of Changes
Other Study ID Numbers: NIH1K23NS078345-01
Study First Received: May 10, 2013
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
migraine
obesity
low fat diet
low carbohydrate diet

Additional relevant MeSH terms:
Obesity
Migraine Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014