Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360148
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
IRCCS San Raffaele
Information provided by (Responsible Party):
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).

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 6, 2020
Estimated Primary Completion Date : September 14, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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.




Primary Outcome Measures :
  1. Change in migraine frequency [ 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) ]
    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 :
  1. Impact of migraine episode on daily activities [ 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) ]

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

    HIT-6 total score: 36-78


  2. Weight loss [ 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) ]
    Physical examination will be carried out in each visit. Weight will be detected

  3. Change in immune system parameters [ Time Frame: 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.

  4. Health-related quality of life [ Time Frame: 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.


  5. change in analgesic consumption [ Time Frame: through study completion, an average of 24 weeks ]
    On migraine-diary, subjects will reported analgesic consumption during diet-treatment

  6. Measure of pain [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360148


Locations
Layout table for location information
Italy
IRCCS San Raffaele Pisana
Rome, Italy, 00163
Sponsors and Collaborators
New Penta SRL
IRCCS San Raffaele
Investigators
Layout table for investigator information
Principal Investigator: Piero Barbanti, Prof. IRCCS San Raffaele Pisana, 00163 Rome-Italy
Publications:

Layout table for additonal information
Responsible Party: New Penta SRL
ClinicalTrials.gov Identifier: NCT04360148    
Other Study ID Numbers: RP 19/23
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by New Penta SRL:
VLCKD
migraine
diet
weight loss
ketone bodies
inflammatory state
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Brain Diseases
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Headache Disorders, Primary
Headache Disorders
Central Nervous System Diseases
Nervous System Diseases