Very Low Calories Ketogenic Diet in Migraine.
Condition: Migraine; Overweight and Obesity
MeSH terms: Migraine Disorders; Overweight
Study type: Interventional

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.
    

Intervention name(s): Ketogenic diet; Sham Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): Very Low Calories Ketogenic Diet; Non-Ketogenic Very Low Calories Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketogenic Diet; Very low calories diet; ketone bodies