Very Low Calories Ketogenic Diet in Migraine.

Migraine Clinical Trial

— Ketomig  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076060
• Other study ID #: ChEmicrania
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: October 24, 2017
• Start date: January 1, 2017
• Est. completion date: October 23, 2017

Study information

• Verified date: October 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 23, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Overweight
• Overweight and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine attacks frequency	number of attacks per month	one-month
Secondary	Migraine days	number of days with migraine per month	one-month
Secondary	Drug consumption	number of symptomatic drugs assumed per month to treat migraine	one-month

External Links

•   In this interview we explain our studies in this field