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

Not Applicable

• Conditions: Ketogenic Dieting; Weight Loss; Brain Diseases; Migraine; Overweight
• Interventions: Other: hypocaloric-balanced-diet; Dietary Supplement: very-low-calorie-ketogenic-diet

• Registration Number: NCT04360148
• Lead Sponsor: New Penta SRL

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) hypocaloric balanced non ketogenic-diet (HBD).

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 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.

Study Timeline

• Study Start: 2020-02-06
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-09-14
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypocaloric-balanced-diet	hypocaloric-balanced-diet	Hypocaloric-balanced-diet (HBD)
Very-low-calorie-ketogenic-diet	very-low-calorie-ketogenic-diet	Very-low-calorie-ketogenic-diet (VLCKD) for 12 weeks; hypocaloric-balanced-diet (HBD)

Primary Outcome Measures

Name	Time	Method
Change in migraine frequency	at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7)	Migraine Disability Assessment Score Questionnaire (MIDAS) is used in order to evaluate how severity migraine affects patient's life. MIDAS score: 0-25

Secondary Outcome Measures

Name	Time	Method
Impact of migraine episode on daily activities	at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7)	Headache Impact Test (HIT-6) is used in order to determine how severely migraine impacts on daily activities.; HIT-6 total score: 36-78
Weight loss	at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6) and at 24 weeks -the end of follow-up (V7)	Physical examination will be carried out in each visit. Weight will be detected
Change in immune system parameters	at the screening (V1),at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6)	Immune system plays a key role in overweight subjects susceptibility to inflammatory diseases. Lymphocyte subpopulation will be studied before and after VLCKD or HBD through blood tests.
Health-related quality of life	at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6)	Health Survey-36 (SF-36) is used in order to evaluate the impact of migraine on quality of life.; SF-36 score: The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
change in analgesic consumption	through study completion, an average of 24 weeks	On migraine-diary, subjects will reported analgesic consumption during diet-treatment
Measure of pain	at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6)	Visual analogue scale (VAS) is used in order to evaluate pain intensity. VAS score: 0-10

Trial Locations

Locations (1)

IRCCS San Raffaele Pisana; 🇮🇹 Rome, Italy