Very Low Calories Ketogenic Diet in Migraine.

NCT03076060 | Completed DMC

• 1 other identifier: ChEmicrania
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Overweight and Obesity

Keywords

Ketogenic Diet; Very low calories diet; ketone bodies

Outcome Measures

Primary Outcomes (1)

• Migraine attacks frequency

  number of attacks per month

  one-month

Secondary Outcomes (2)

• Migraine days

  one-month

• Drug consumption

  one-month

Study Arms (2)

Migraineurs

EXPERIMENTAL

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

Sham diet migraineurs

SHAM COMPARATOR

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

Interventions

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.

Also known as: Very Low Calories Ketogenic Diet

Migraineurs

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.

Also known as: Non-Ketogenic Very Low Calories Diet

Sham diet migraineurs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, 00161, Italy

Location

Related 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. Epub 2014 Aug 25.

  PMID: 25156013 RESULT

MeSH Terms

Conditions

Migraine Disorders; Overweight; Obesity

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Francesco Pierelli

  Sapienza Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: October 23, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)