Very Low Calories Ketogenic Diet in Migraine. (Ketomig)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Overweight and Obesity
• Intervention / Treatment: Behavioral: Ketogenic diet; Behavioral: Sham Diet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Policlinico Umberto I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• kept a headache diary for at least 1 month
• migraine disease onset before the age of 50
• at least one migraine attack per month in the last 3 months
• <15 days/month with headaches.

Exclusion Criteria:

• prophylactic treatment in the previous 3 months
• over consumption of acute anti-migraine medication (triptan, analgesic, or ergotamine)
• pregnancy or lactation
• type I diabetes
• serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Migraineurs; Overweighted or Obese migraineurs that refer to a dietician clinic to treat their ponderal condition. Intervention: 4-week of VLCKD by meal replacements poor in fats and carbohydrates.	Behavioral: Ketogenic diet; Two different kind of diet, a Very Low Calories Ketogenic Diet (KD) and a sham weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. To avoid the bias of different caloric intake, SD group will undergo to a non-ketogenic Very Low Calories Diet . Randomly patients will start with KD or SD. Patients assigned to this arm will follow the KD.; Other Names: Very Low Calories Ketogenic Diet
Sham Comparator: Sham diet migraineurs; Overweighted or Obese migraineurs that refer to a dietician clinic to treat their ponderal condition. Intervention: 4-week of non-ketogenic VLCD by meal replacements poor in fats and proteins.	Behavioral: Sham Diet; Two different kind of diet, a Very Low Calories Ketogenic Diet (KD) and a sham weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. To avoid the bias of different caloric intake, SD group will undergo to a non-ketogenic Very Low Calories Diet . Randomly patients will start with KD or SD. Patients assigned to this arm will follow the SD.; Other Names: Non-Ketogenic Very Low Calories Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine attacks frequency	number of attacks per month	one-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine days	number of days with migraine per month	one-month
Drug consumption	number of symptomatic drugs assumed per month to treat migraine	one-month

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Francesco Pierelli, Sapienza Univeristy

Publications and helpful links

General Publications

• Di Lorenzo C, Coppola G, Sirianni G, Di Lorenzo G, Bracaglia M, Di Lenola D, Siracusano A, Rossi P, Pierelli F. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol. 2015 Jan;22(1):170-7. doi: 10.1111/ene.12550. Epub 2014 Aug 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): October 23, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Ketogenic Diet; ketone bodies; Very low calories diet
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Weight; Headache Disorders, Primary; Headache Disorders; Overweight; Migraine Disorders
• Other Study ID Numbers: ChEmicrania

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No