Diet and Migraine Study

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01859052
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 3
• Duration (Months): 34
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine; Obesity	Other: Low carbohydrate diet; Other: Low calorie low fat diet; Other: AHA diet recommendations	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Diet and Migraine Study
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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
Other: 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.

Outcome Measures

Primary Outcome Measures

1. Mean change in headache frequency [3 months.]

   Change in headache frequency from baseline to 3 months

2. Mean change in body composition [3 months]

   The mean change in body composition from the baseline phase to 3 months

3. The mean change in inflammatory markers [3 month]

   The mean change in inflammatory markers from baseline to 3 months

Secondary Outcome Measures

1. Proportion of patients responding to treatment [3 months]

   Proportion of participants responding to weight loss program as measured by a 21% or more reduction in mean monthly migraine frequency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	The Johns Hopkins Bayview Headache Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Barbara L Peterlin, DO, The Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Drs Barbara Peterlin, Director of Headache Research, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01859052
• Other Study ID Numbers: NIH1K23NS078345-01
• First Posted: May 21, 2013
• Last Update Posted: Sep 2, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Drs Barbara Peterlin, Director of Headache Research, Johns Hopkins University: migraine; obesity; low fat diet; low carbohydrate diet
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Sep 2, 2015