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

Sponsor

New Penta SRL (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04360148

Collaborator

IRCCS San Raffaele (Other)

Enrollment

Location

Arms

15.7

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Migraine Ketogenic Dieting Weight Loss Overweight Brain Diseases	Dietary Supplement: very-low-calorie-ketogenic-diet Other: hypocaloric-balanced-diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Randomized-controlled Study for Evaluation of Ketogenic Metabolic Nutritional Pattern in Subjects With High-frequency Episodic Migraine

Actual Study Start Date :

Feb 6, 2020

Anticipated Primary Completion Date :

Sep 14, 2020

Anticipated Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Very-low-calorie-ketogenic-diet Very-low-calorie-ketogenic-diet (VLCKD) for 12 weeks; hypocaloric-balanced-diet (HBD)	Dietary Supplement: very-low-calorie-ketogenic-diet VLCKD-group will undergone to VLCKD for 8 weeks. VLCKD is based on protein preparations of high biological value. Total daily energy intake is < 800 kcal.Daily carbohydrate intake is lower than 30 g/day, while daily protein intake is approximately 1.2-1.5 g/kg of ideal body weight. 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.
Active Comparator: Hypocaloric-balanced-diet Hypocaloric-balanced-diet (HBD)	Other: hypocaloric-balanced-diet HBD-group will undergone to hypo caloric balanced diet for 24 weeks. Total daily average energy intake is 1500-1600 kcal/day. 30% of total daily energy is composed by lipids (10% MUFA, 10% PUFA, 10% SFA), 55% carbohydrates, while daily protein intake is approximately 0.8-1.5 g /kg of ideal body weight.

Arm

Intervention/Treatment

Experimental: Very-low-calorie-ketogenic-diet

Very-low-calorie-ketogenic-diet (VLCKD) for 12 weeks; hypocaloric-balanced-diet (HBD)

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

VLCKD-group will undergone to VLCKD for 8 weeks. VLCKD is based on protein preparations of high biological value. Total daily energy intake is < 800 kcal.Daily carbohydrate intake is lower than 30 g/day, while daily protein intake is approximately 1.2-1.5 g/kg of ideal body weight. 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.

Active Comparator: Hypocaloric-balanced-diet

Hypocaloric-balanced-diet (HBD)

Other: hypocaloric-balanced-diet

HBD-group will undergone to hypo caloric balanced diet for 24 weeks. Total daily average energy intake is 1500-1600 kcal/day. 30% of total daily energy is composed by lipids (10% MUFA, 10% PUFA, 10% SFA), 55% carbohydrates, while daily protein intake is approximately 0.8-1.5 g /kg of ideal body weight.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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