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MigraineEMIKETONCT04360148

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

A study testing very-low-calorie-ketogenic-diet and hypocaloric-balanced-diet in people with Migraine and Ketogenic Dieting, run by New Penta SRL at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine, Ketogenic Dieting, Weight Loss
What is being tested?
very-low-calorie-ketogenic-diet and hypocaloric-balanced-diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteItaly
Study dates
6 Feb 2020to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Raffaele Pisana

    Rome, 00163

Other trials in Italy

About this study

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

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).

Read the 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.

Being tested
very-low-calorie-ketogenic-diet, hypocaloric-balanced-diet
Keywords
VLCKD, migraine, diet, weight loss, ketone bodies, inflammatory state
Medical subject headings
Migraine Disorders, Weight Loss, Overweight, Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • very-low-calorie-ketogenic-dietDietary supplement

    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.

  • hypocaloric-balanced-dietOther

    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.

Study groups in NCT04360148
Study groupRoleWhat they receive
Very-low-calorie-ketogenic-dietExperimentalVery-low-calorie-ketogenic-diet (VLCKD) for 12 weeks; hypocaloric-balanced-diet (HBD)
Receives: Dietary Supplement: very-low-calorie-ketogenic-diet
Hypocaloric-balanced-dietActive comparatorHypocaloric-balanced-diet (HBD)
Receives: Other: hypocaloric-balanced-diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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 outcomes (6)

  1. 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

    Measured: 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)

  2. Weight loss

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

    Measured: 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)

  3. 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.

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

  4. 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.

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

  5. change in analgesic consumption

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

    Measured: through study completion, an average of 24 weeks

  6. Measure of pain

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start6 Feb 2020
  3. Primary completion14 Sep 2020 (estimated)
  4. Study completion30 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360148
Sponsor's protocol ID
RP 19/23
Acronym
EMIKETO
Status last verified
Apr 2020
First submitted
15 Apr 2020
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.

    PubMed 28931491

  • Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.

    PubMed 17261680

  • Bigal ME, Lipton RB, Holland PR, Goadsby PJ. Obesity, migraine, and chronic migraine: possible mechanisms of interaction. Neurology. 2007 May 22;68(21):1851-61. doi: 10.1212/01.wnl.0000262045.11646.b1.

    PubMed 17515549

  • Bond DS, Roth J, Nash JM, Wing RR. Migraine and obesity: epidemiology, possible mechanisms and the potential role of weight loss treatment. Obes Rev. 2011 May;12(5):e362-71. doi: 10.1111/j.1467-789X.2010.00791.x.

    PubMed 20673279

  • Peterlin BL, Sacco S, Bernecker C, Scher AI. Adipokines and Migraine: A Systematic Review. Headache. 2016 Apr;56(4):622-44. doi: 10.1111/head.12788. Epub 2016 Mar 25.

    PubMed 27012149

  • Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.

    PubMed 26641646

  • Basciani S, Costantini D, Contini S, Persichetti A, Watanabe M, Mariani S, Lubrano C, Spera G, Lenzi A, Gnessi L. Safety and efficacy of a multiphase dietetic protocol with meal replacements including a step with very low calorie diet. Endocrine. 2015 Apr;48(3):863-70. doi: 10.1007/s12020-014-0355-2. Epub 2014 Jul 26.

    PubMed 25063307

  • Ellulu MS, Patimah I, Khaza'ai H, Rahmat A, Abed Y. Obesity and inflammation: the linking mechanism and the complications. Arch Med Sci. 2017 Jun;13(4):851-863. doi: 10.5114/aoms.2016.58928. Epub 2016 Mar 31.

    PubMed 28721154

  • Lutas A, Yellen G. The ketogenic diet: metabolic influences on brain excitability and epilepsy. Trends Neurosci. 2013 Jan;36(1):32-40. doi: 10.1016/j.tins.2012.11.005. Epub 2012 Dec 8.

    PubMed 23228828

  • Klosinski LP, Yao J, Yin F, Fonteh AN, Harrington MG, Christensen TA, Trushina E, Brinton RD. White Matter Lipids as a Ketogenic Fuel Supply in Aging Female Brain: Implications for Alzheimer's Disease. EBioMedicine. 2015 Nov 3;2(12):1888-904. doi: 10.1016/j.ebiom.2015.11.002. eCollection 2015 Dec.

    PubMed 26844268

  • Paoli A, Bianco A, Damiani E, Bosco G. Ketogenic diet in neuromuscular and neurodegenerative diseases. Biomed Res Int. 2014;2014:474296. doi: 10.1155/2014/474296. Epub 2014 Jul 3.

    PubMed 25101284

  • de Almeida Rabello Oliveira M, da Rocha Ataide T, de Oliveira SL, de Melo Lucena AL, de Lira CE, Soares AA, de Almeida CB, Ximenes-da-Silva A. Effects of short-term and long-term treatment with medium- and long-chain triglycerides ketogenic diet on cortical spreading depression in young rats. Neurosci Lett. 2008 Mar 21;434(1):66-70. doi: 10.1016/j.neulet.2008.01.032. Epub 2008 Jan 19.

    PubMed 18281154

  • Bough KJ, Wetherington J, Hassel B, Pare JF, Gawryluk JW, Greene JG, Shaw R, Smith Y, Geiger JD, Dingledine RJ. Mitochondrial biogenesis in the anticonvulsant mechanism of the ketogenic diet. Ann Neurol. 2006 Aug;60(2):223-35. doi: 10.1002/ana.20899.

    PubMed 16807920

  • Mattson MP, Moehl K, Ghena N, Schmaedick M, Cheng A. Intermittent metabolic switching, neuroplasticity and brain health. Nat Rev Neurosci. 2018 Feb;19(2):63-80. doi: 10.1038/nrn.2017.156. Epub 2018 Jan 11.

    PubMed 29321682

  • Waeber C, Moskowitz MA. Migraine as an inflammatory disorder. Neurology. 2005 May 24;64(10 Suppl 2):S9-15. doi: 10.1212/wnl.64.10_suppl_2.s9. No abstract available.

    PubMed 15911785

Questions about this trial

What is this clinical trial studying?

A study testing very-low-calorie-ketogenic-diet and hypocaloric-balanced-diet in people with Migraine and Ketogenic Dieting, run by New Penta SRL at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04360148, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.

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