Status:
UNKNOWN
Th Effect of Ketogenic Metabolic Nutritional Pattern on High-frequency Episodic Migraine (EMIKETO)
Lead Sponsor:
New Penta SRL
Collaborating Sponsors:
IRCCS San Raffaele
Conditions:
Migraine
Ketogenic Dieting
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b)...
Detailed Description
This randomized controlled trial aims to: * investigate the impact of very-low-calorie-ketogenic-diet (VLCKD) compared to hypocaloric balanced non ketogenic-diet (HBD) on high-frequency episodic migr...
Eligibility Criteria
Inclusion
- Body mass index \>27 kg/m2
- Migraine onset \<50 years with monthly frequency of 8-14 days in the last 3 months
- Absence of prophylaxis therapy for migraine in the previous 3 months
- Signing of the informed consent
- Agreement to follow all study procedures, including follow-up visits
- Negative pregnancy test, performed on urine sample
- Use of contraceptive method for all participants throughout the duration of the study
- Agreement for all study participants not to publish study information
Exclusion
- Body mass index\> 35 kg / m2;
- prophylaxis treatment for migraine in the previous 3 months
- antidepressant and neuroleptic drugs treatment during the study (including follow-up)
- non-potassium-sparing diuretics treatment during the study (including follow-up)
- Use or implantation of stimulators for migraine
- Migraine with or without excessive drug use, tension-type headache, cluster headache, sporadic or familial hemiplegic migraine, ophthalmoplegic migraine, basic migraine defined according to the ICHD-3 beta classification in the previous 3 months
- head trauma
- psychiatric diseases that can influence adherence to treatment
- Type I diabetes mellitus or type II diabetes mellitus treated with insulin therapy
- Taking supplements which affect weight
- Taking supplements containing sugars in their composition
- Pregnancy or breastfeeding
- Abuse of alcohol
- Other neurological, cardiovascular, liver, respiratory, hematologic, autoimmune diseases or alterations to laboratory tests that could compromise the study
Key Trial Info
Start Date :
February 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04360148
Start Date
February 6 2020
End Date
May 30 2021
Last Update
April 24 2020
Active Locations (1)
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1
IRCCS San Raffaele Pisana
Rome, Italy, 00163