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Completed

NCT Number: NCT03076060

Very Low Calories Ketogenic Diet in Migraine.

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.

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Key information

Conditions

Migraine Body Weight Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Umberto I

Rome, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketogenic diet

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.

Other names: Very Low Calories Ketogenic Diet

Sham Diet

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.

Other names: Non-Ketogenic Very Low Calories Diet

Primary outcomes

  1. Migraine attacks frequency

    Time frame: one-month

    number of attacks per month

Secondary outcomes

  1. Migraine days

    Time frame: one-month

    number of days with migraine per month

  2. Drug consumption

    Time frame: one-month

    number of symptomatic drugs assumed per month to treat migraine

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: Ketomig

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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