Th Effect of Ketogenic Metabolic Nutritional Pattern on High-frequency Episodic Migraine (EMIKETO)

New Penta

Status

Unknown

Conditions

Weight Loss

Overweight

Ketogenic Dieting

Migraine

Brain Diseases

Treatments

Other: hypocaloric-balanced-diet

Dietary Supplement: very-low-calorie-ketogenic-diet

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04360148

RP 19/23

Details and patient eligibility

About

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) hypocaloric balanced non ketogenic-diet (HBD).

Full 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 migraine
evaluate the impact of VLCKD or HBD on immune system, with particular regard to inflammatory and regulatory T cells
assess aldosterone blood levels before and after VLCKD or HBD treatment The randomization will be carry out at the single center using an a proper software.

All the eligible subjects (please, see the inclusion and exclusion criteria), will be randomized in two groups. Both VLCKD or HBD will be undergone to 24 weeks of diet. For VLCKD- group, the ketogenic period will be maintained for 8 weeks. In the following four weeks, carbohydrates are gradually reintroduced, starting from foods with the lowest glycemic index (fruit, dairy products), followed by foods with moderate and high glycemic index (bread, pasta and cereals). The goal is to achieve a hypocaloric balanced diet (HBD), as well as the controlled group. From the 12th week to the 24 th week, all subjects enrolled will continue follow-up with HBD. Periodically, subjects will be monitored through physical examination (anthropometric measurements, blood pressure, heart rate, etc.) and laboratory analysis.

Enrollment

58 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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