An interventional study of Low carbohydrate diet and Low calorie low fat diet in Migraine and Obesity, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to female participants aged 19 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-02.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low carbohydrate diet
Other: Low carbohydrate diet · Other: Low calorie low fat diet
Obese Migraineurs
Other: Low carbohydrate diet · Other: Low calorie low fat diet
Controls receiving AHA diet recommendations
Other: AHA diet recommendations
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.
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
given information in accordance with the diet and lifestyle recommendations of the American Heart Association.
Mean change in headache frequency
Change in headache frequency from baseline to 3 months
Time frame: 3 months.
Mean change in body composition
The mean change in body composition from the baseline phase to 3 months
Time frame: 3 months
The mean change in inflammatory markers
The mean change in inflammatory markers from baseline to 3 months
Time frame: 3 month
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
Time frame: 3 months
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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