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Very Low Calories Ketogenic Diet in Migraine.

NCT03076060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-10-26

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Francesco Pierelli · Sapienza Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-09-01
Completion
2017-10-23

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076060 on ClinicalTrials.gov