Clinical trial NCT01859052: Diet and Migraine Study
Official title: Diet and Migraine Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine
Obesity
Keywords: migraine
obesity
low fat diet
low carbohydrate diet
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 32
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mean change in headache frequency
timeFrame: 3 months.
measure: Mean change in body composition
timeFrame: 3 months
measure: The mean change in inflammatory markers
timeFrame: 3 month
Secondary outcomes:
measure: Proportion of patients responding to treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Bayview Headache Center
state: Maryland
Study officials:
affiliation: The Johns Hopkins University
name: Barbara L Peterlin, DO
role: PRINCIPAL_INVESTIGATOR
References: