Diet and Migraine Study
Primary Purpose
Migraine, Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate diet
Low calorie low fat diet
AHA diet recommendations
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring migraine, obesity, low fat diet, low carbohydrate diet
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
- 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
Sites / Locations
- The Johns Hopkins Bayview Headache Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Obese migraineurs
low-fat diet
Controls
Arm Description
Low carbohydrate diet
Obese Migraineurs
Controls receiving AHA diet recommendations
Outcomes
Primary Outcome Measures
Mean change in headache frequency
Change in headache frequency from baseline to 3 months
Mean change in body composition
The mean change in body composition from the baseline phase to 3 months
The mean change in inflammatory markers
The mean change in inflammatory markers from baseline to 3 months
Secondary Outcome Measures
Proportion of patients responding to treatment
Proportion of participants responding to weight loss program as measured by a 21% or more reduction in mean monthly migraine frequency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01859052
Brief Title
Diet and Migraine Study
Official Title
Diet and Migraine Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Study team was unable to effectively conduct the study.
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Obesity
Keywords
migraine, obesity, low fat diet, low carbohydrate diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese migraineurs
Arm Type
Other
Arm Description
Low carbohydrate diet
Arm Title
low-fat diet
Arm Type
Other
Arm Description
Obese Migraineurs
Arm Title
Controls
Arm Type
Other
Arm Description
Controls receiving AHA diet recommendations
Intervention Type
Other
Intervention Name(s)
Low carbohydrate diet
Intervention Description
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
Intervention Name(s)
Low calorie low fat diet
Intervention Description
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
Intervention Name(s)
AHA diet recommendations
Intervention Description
given information in accordance with the diet and lifestyle recommendations of the American Heart Association.
Primary Outcome Measure Information:
Title
Mean change in headache frequency
Description
Change in headache frequency from baseline to 3 months
Time Frame
3 months.
Title
Mean change in body composition
Description
The mean change in body composition from the baseline phase to 3 months
Time Frame
3 months
Title
The mean change in inflammatory markers
Description
The mean change in inflammatory markers from baseline to 3 months
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Proportion of patients responding to treatment
Description
Proportion of participants responding to weight loss program as measured by a 21% or more reduction in mean monthly migraine frequency
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara L Peterlin, DO
Organizational Affiliation
The Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins Bayview Headache Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
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Diet and Migraine Study
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