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

Primary Purpose

Migraine, Ketogenic Dieting, Weight Loss

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

very-low-calorie-ketogenic-diet

hypocaloric-balanced-diet

About this trial

This is an interventional prevention trial for Migraine focused on measuring VLCKD, migraine, diet, weight loss, ketone bodies, inflammatory state

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

IRCCS San Raffaele Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Very-low-calorie-ketogenic-diet

Hypocaloric-balanced-diet

Arm Description

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

Hypocaloric-balanced-diet (HBD)

Outcomes

Primary Outcome Measures

Change in migraine frequency

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

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

Physical examination will be carried out in each visit. Weight will be detected

Change in immune system parameters

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

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

On migraine-diary, subjects will reported analgesic consumption during diet-treatment

Measure of pain

Visual analogue scale (VAS) is used in order to evaluate pain intensity. VAS score: 0-10

Full Information

NCT ID

NCT04360148

First Posted

April 15, 2020

Last Updated

April 21, 2020

Sponsor

New Penta SRL

Collaborators

IRCCS San Raffaele

1. Study Identification

Unique Protocol Identification Number

NCT04360148

Brief Title

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

Acronym

EMIKETO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 6, 2020 (Actual)

Primary Completion Date

September 14, 2020 (Anticipated)

Study Completion Date

May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New Penta SRL

Collaborators

IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine, Ketogenic Dieting, Weight Loss, Overweight, Brain Diseases

Keywords

VLCKD, migraine, diet, weight loss, ketone bodies, inflammatory state

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Very-low-calorie-ketogenic-diet

Arm Type

Experimental

Arm Description

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

Arm Title

Hypocaloric-balanced-diet

Arm Type

Active Comparator

Arm Description

Hypocaloric-balanced-diet (HBD)

Intervention Type

Dietary Supplement

Intervention Name(s)

very-low-calorie-ketogenic-diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

hypocaloric-balanced-diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in migraine frequency

Description

Migraine Disability Assessment Score Questionnaire (MIDAS) is used in order to evaluate how severity migraine affects patient's life. MIDAS score: 0-25

Time Frame

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)

Secondary Outcome Measure Information:

Title

Impact of migraine episode on daily activities

Description

Headache Impact Test (HIT-6) is used in order to determine how severely migraine impacts on daily activities. HIT-6 total score: 36-78

Time Frame

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)

Title

Weight loss

Description

Physical examination will be carried out in each visit. Weight will be detected

Time Frame

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)

Title

Change in immune system parameters

Description

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.

Time Frame

at the screening (V1),at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6)

Title

Health-related quality of life

Description

Time Frame

at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6)

Title

change in analgesic consumption

Description

On migraine-diary, subjects will reported analgesic consumption during diet-treatment

Time Frame

through study completion, an average of 24 weeks

Title

Measure of pain

Description

Visual analogue scale (VAS) is used in order to evaluate pain intensity. VAS score: 0-10

Time Frame

at baseline (V2), at 8 weeks- the end ok ketogenic period (V5) and at 12 weeks-the end of diet (V6)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piero Barbanti, Prof.

Organizational Affiliation

IRCCS San Raffaele Pisana, 00163 Rome-Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS San Raffaele Pisana

City

Rome

ZIP/Postal Code

00163

Country

Italy

12. IPD Sharing Statement

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

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