Very Low Calories Ketogenic Diet in Migraine. — Ketomig  

Migraine Clinical Trial

Official title: Randomised Controlled Crossover Double-blind Study on Very Low Calories Ketogenic Diet in Overweighted Migraine Patients.

Status Completed

Clinical Trial Summary

Ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (KD), a drastic restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (KB) synthesis. We followed, in a dietician clinical setting, a group of migraineurs who randomly received a one-month prescription of experimental diet, followed by a one-month of carbohydrate progressive reintroduction, then another one-month of experimental diet, followed by a one-month of carbohydrate progressive reintroduction. Experimental diets are a very-low calorie KD, or an isocaloric non-ketogenic diet.

Aim of our study is verify if during ketogenesis migraine improves.

Clinical Trial Description

The ketogenic diet (KD) is a high-fat, low-carbohydrate diet for long used to treat refractory epilepsy. Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients following low-carbohydrate low-calorie diets for rapid weight loss. Different Authors evidenced a protective effect of ketone bodies also on migraine; however, KD effectiveness in this disorder is under scrutiny yet again. In fact, some concerns makes the matter a still open question: available studies were anecdotal, or conducted on small numbers; not all patients were diagnosed as migraineurs according to current headache classification; during ketogenesis there could be an avoidance of potentially trigger foods. Moreover, to comply with ketogenic diet, great motivation is needed and often migraineurs did not have it.

Aim of this study is verify in a double blind parallel group cross over design if ketogenesis is really able to prevent/avoid headache attacks in episodic migraineurs.

Methods: Thirty-five consecutive episodic migraineurs, with an attack frequency higher than 2 attacks per months, will be enrolled. Two different kind of diet, a KD and a standard weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. Randomly patients will start with KD or SD. At the end of the second month differences between diets will be detected.

KD will consist of 4 daily pharmaceutical meal substitutes composed by low-carbohydrate, low-fat, rich in protein serving of food, already commercially available. SD will consist in a similar eating program, with serving of food with addition of carbohydrate to avoid ketogenesis. ;

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Overweight
• Overweight and Obesity

• NCT number: NCT03076060
• Study type: Interventional
• Source: University of Roma La Sapienza
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Completion date: October 23, 2017