Very Low Calories Ketogenic Diet in Migraine.

NCT ID: NCT03076060

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-10-23

Brief 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.

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.

Conditions

Migraine; Overweight and Obesity

Keywords

Ketogenic Diet; Very low calories diet; ketone bodies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketogenic diet

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Sham Diet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Very Low Calories Ketogenic Diet; Non-Ketogenic Very Low Calories Diet

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Cherubino DI LORENZO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Pierelli

Role: STUDY_DIRECTOR

Sapienza Univeristy

Locations

Policlinico Umberto I

Rome, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 25156013 (View on PubMed)

Other Identifiers

ChEmicrania

Identifier Type: -

Identifier Source: org_study_id