Diet and Migraine Study

Obesity Clinical Trial

Official title:

Diet and Migraine Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01859052
• Other study ID #: NIH1K23NS078345-01
• Status: Terminated
• Phase: N/A
• First received: May 10, 2013
• Last updated: August 31, 2015
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Obesity

Intervention

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.
• 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
• AHA diet recommendations
given information in accordance with the diet and lifestyle recommendations of the American Heart Association.

Locations

Country	Name	City	State
United States	The Johns Hopkins Bayview Headache Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in headache frequency	Change in headache frequency from baseline to 3 months	3 months.	No
Primary	Mean change in body composition	The mean change in body composition from the baseline phase to 3 months	3 months	No
Primary	The mean change in inflammatory markers	The mean change in inflammatory markers from baseline to 3 months	3 month	No
Secondary	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	3 months	No