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Very Low Calories Ketogenic Diet in Migraine. (Ketomig)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Cherubino DI LORENZO, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT03076060
First received: March 6, 2017
Last updated: March 12, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Migraine
Overweight and Obesity
Behavioral: Ketogenic diet
Behavioral: Sham Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Randomised Controlled Crossover Double-blind Study on Very Low Calories Ketogenic Diet in Overweighted Migraine Patients.

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Migraine attacks frequency [ Time Frame: one-month ]
    number of attacks per month


Secondary Outcome Measures:
  • Migraine days [ Time Frame: one-month ]
    number of days with migraine per month

  • Drug consumption [ Time Frame: one-month ]
    number of symptomatic drugs assumed per month to treat migraine


Estimated Enrollment: 35
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: October 31, 2017
Estimated Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Non-Ketogenic Very Low Calories 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03076060

Contacts
Contact: Cherubino Di Lorenzo, MD, PhD +393286783246 cherubino.dilorenzo@uniroma1.it

Locations
Italy
Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Cherubino Di Lorenzo, MD, PhD    +393286783246    cherubino.dilorenzo@uniroma1.it   
Contact: Alessandro Pinto, MD, PhD       alessandro.pinto@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: Francesco Pierelli Sapienza Univeristy
  More Information

Additional Information:
Publications:
Responsible Party: Cherubino DI LORENZO, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03076060     History of Changes
Other Study ID Numbers: ChEmicrania
Study First Received: March 6, 2017
Last Updated: March 12, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: We do not share data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Roma La Sapienza:
Ketogenic Diet
Very low calories diet
ketone bodies

Additional relevant MeSH terms:
Overweight
Migraine Disorders
Body Weight
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 27, 2017