Diet and Migraine Study

NCT01859052 | Terminated

• 1 other identifier: NIH1K23NS078345-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Obesity

Keywords

migraine; obesity; low fat diet; low carbohydrate diet

Outcome Measures

Primary Outcomes (3)

• Mean change in headache frequency

  Change in headache frequency from baseline to 3 months

  3 months.

• Mean change in body composition

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

  3 months

• The mean change in inflammatory markers

  The mean change in inflammatory markers from baseline to 3 months

  3 month

Secondary Outcomes (1)

• Proportion of patients responding to treatment

  3 months

Study Arms (3)

Obese migraineurs

OTHER

Low carbohydrate diet

Other: Low carbohydrate diet; Other: Low calorie low fat diet

low-fat diet

OTHER

Obese Migraineurs

Other: Low carbohydrate diet; Other: Low calorie low fat diet

Controls

OTHER

Controls receiving AHA diet recommendations

Other: AHA diet recommendations

Interventions

Low carbohydrate diet OTHER

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.

Obese migraineurs; low-fat diet

Low calorie low fat diet OTHER

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

Obese migraineurs; low-fat diet

AHA diet recommendations OTHER

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

Controls

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Obesity

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Barbara L Peterlin, DO

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Headache Research

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 21, 2013
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

US (1)