Epilepsy IntractableNCT07714226
A Multifaceted Assessment of Eating Behaviors, Anthropometric Measurements and Body Composition in Pediatric Patients With Drug-resistant Epilepsy on a Ketogenic Diet and Healthy Children
An observational study of Epilepsy Intractable, run by Wroclaw Medical University at 2 sites in Poland.
Trial summary
The goal of this observational study is to compare the prevalence and severity of eating behaviors-such as food neophobia, picky eating, food fussiness, meal repetition and variety, and food texture preferences-between healthy children and children with drug-resistant epilepsy on a ketogenic diet. Read more about this study
- Who is it for?
- Ages 2 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy Intractable
- How many people
- 150 participants
- Where
- 2 sitesPoland
- Study dates
- 12 Apr 2023to 12 Dec 2027
- Phase
- Observational
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 2 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The entire population of pediatric patients with drug-resistant epilepsy (n=22 individuals) using a ketogenic diet for therapeutic purposes from the only public hospital center in Lower Silesia prescribing this type of treatment, i.e., the T. Marciniak Lower Silesian Specialist Hospital in Wrocław, Poland, was invited to the study group, along with 22 parents or legal guardians of the children. It was assumed that the control group should reflect the study group in terms of age and place of residence. For this purpose, a matched group of 100 residents of Lower Silesia was created. 50% of them resided in Wrocław (the capital of Lower Silesia; >100,000 inhabitants), and 50% were individuals residing in 16 various localities in Lower Silesia with <100,000 inhabitants. Each group (n=50), divided by place of residence, included 3 age subgroups, analogous to the age of the study group: younger children - 3-6 years old attending preschool, children from early primary school grades, 7-10 y.
Who may be able to join
- consent of the child and guardians/caregivers to participate in the study,
- diagnosis of drug-resistant epilepsy and use of a ketogenic diet for at least 3 months,
- age above 2 years, full or partial use of an oral diet (to an extent that allows the child to express their food preferences)
- possibility of measuring RMR via indirect calorimetry
- consent of the parent and child to participate in the study
- absence of chronic diseases, no permanent use of medications
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- no diagnoses/certificates from a pedagogical-psychological counseling center, e.g., dyslexia, dysgraphia, social relationship disorders, no diagnoses such as Asperger's, Autism, or other spectrum disorders or nervous system function disorders
- ability to perform anthropometric measurements
- Polish citizenship and residence in Poland
- residence in the Lower Silesia region.
Who cannot join
- lack of consent from the child and guardians/caregivers to participate in the study
- non-adherence to ketogenic diet recommendations,
- 100% nutrition supply via PEG (n=2),
- age below 2 years (n=2)
- treatment at a clinical center other than the Lower Silesian one
- inability to perform anthropometric measurements and RMR
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- lack of consent to perform/participate in the study
- chronic diseases including neurological disorders, certificates and/or diagnoses from a psychological-pedagogical counseling center
- use of specialized diets related to illness or exclusion diets (vegetarian, vegan, ketogenic diet)
- chronic use of medications related to illness, inability to perform anthropometric measurements and RMR meaurements.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Dolnośląski Szpital Specjalistyczny im. T.Marciniaka
Wroclaw, Lower Silesian Voivodeship
Wroclaw Medical University - Pharmacy Faculty
Wroclaw, Lower Silesian Voivodeship
About this study
The goal of this observational study is to compare the prevalence and severity of eating behaviors-such as food neophobia, picky eating, food fussiness, meal repetition and variety, and food texture preferences-between healthy children and children with drug-resistant epilepsy on a ketogenic diet. It will also compare anthropometric measurements, body composition, and resting metabolic rate (RMR) between the groups. The study seeks to identify key aversive eating behaviors that could potentially affect diet quality.
Participants-children already following the ketogenic diet-will answer questionnaires about eating behaviors and be measured (weight, height, skinfold thickness, and resting metabolic rate). Parents will also answer questionnaires about their children's eating behaviors. Researchers will compare eating behaviors and anthropometric measurements with those of healthy children.
Read the detailed description
It is planned to measure the participants' height and weight. The following measurements will be taken among the study participants: height, using a free-standing, portable Tanita HR-001 (Tanita, Tokyo, Japan) stadiometer, and weight, using a Tanita BC 545 scale (Tanita, Tokyo, Japan). Additionally, the thickness of skinfolds above and below the biceps, below the shoulder blade (subscapular), and above the iliac crest (suprailiac) will be measured. Furthermore, calf, arm, and waist circumferences will be measured.
Based on the data obtained, BMI will be calculated and compared against the OLA and OLAF percentile growth charts dedicated to the Polish pediatric population. As recommended, <5th percentile will be adopted as underweight, 5th-85th percentile as normal weight, >85th percentile as overweight, and >95th percentile as obesity.
Furthermore, based on body weight, circumference, and skinfold thickness, an assessment of body fat content is planned.
To assess dietary habits, parents and children from both the study and control groups, together with a qualified dietitian, will complete the following questionnaires: the Modified Children's Food Neophobia Scale (Modified CFNS) (parent), the Children's Eating Behavior Questionnaire (CEBQ) (parent), and the Child Food Texture Preference Questionnaire (CFTPQ) (child), translated into Polish.
To supplement information regarding dietary style, the authors will ask parents of children from both the study and control groups additional questions concerning meal variety, meal repetitiveness, and the occurrence of periods of selective eating. The obtained data will be statistically processed and used to create scientific publications.
In addition, resting metabolic rate will be measured in both groups of children using indirect calorimetry. Participants will undergo an approximately 10-minute indirect calorimetry test while fasting and in a supine position, using a COSMED Fitmate WM calorimeter with an age-appropriate breathing mask. The test will be conducted in the presence of a parent.
The obtained RMR results from indirect calorimetry will be compared to standard RMR prediction equations for children, i.e., the Schofield equation, the FAO/WHO equation, and the equations developed by the Institute of Medicine of the National Academies and the Food and Nutrition Board, and expressed as a percentage of their predicted values.
A comparison of results between the control group and the study group is planned. Furthermore, correlation graphs between the studied variables will be created, as well as a PCA (Principal Component Analysis) chart to assess the occurrence of clustered eating habits present in the pediatric population.
- Conditions
- Epilepsy Intractable
- Keywords
- ketogenic diet, drug resistance epilepsy, eating behaviours, RMR
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group - children with drug-resistant epilepsy on a ketogenic diet | Not described | |
| Control group - healthy children on a standard diet | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of frequency and severity of food neophobia between groups, based on the Modified CFNS.
For Modified Children's Food Neophobia Scale (Modified CFNS) the following cut-off values were adopted to indicate the presence and/or severity of neophobia:
- Values >12 points were considered indicative of a higher degree of food neophobia, and ≤12 points as a lower level of food neophobia. Following other authors, values above M+1SD were adopted as indicative of neophobia.
The mean score values, as well as the percentages of children presenting higher and lower food neophobia, will be compared between groups.
Measured: from enrollment to the end of data collection (03.2026)
Differences in resting metabolic rate values between healthy children and children on a ketogenic diet, based on indirect calorimetry and the percentage of predicted values according to theoretical RMR prediction equations
The obtained RMR results from indirect calorimetry will be compared to standard RMR prediction equations for children, i.e., the Schofield equation, the FAO/WHO equation, and the equations developed by the Institute of Medicine of the National Academies and the Food and Nutrition Board, and expressed and compare as a percentage of their predicted values.
Measured: From enrollment to the end of data collection (03/2026)
Comparison of frequency and severity of eating difficulties between groups, based on CEBQ.
In Children's Eating Behavior Questionnaire (CEBQ) - the following cut-off values were adopted to indicate the presence and/or severity of eating behaviors:
Score levels above 50% of a given subscale were assessed as indicating a higher representation of the corresponding eating style. Results above M±SD were set as indicating a strong representation of a given eating style among children.
The frequency and severity of presented habits assessed in the questionnaire will be compared between groups.
Measured: from enrollment to the end of data collection (03.2026)
Comparison of children's food texture preferences between groups, based on the CFTPQ.
Based on results from The Child Food Texture Preference Questionnaire (CFTPQ) - Scores <25th percentile classified children into the so-called "soft texture likers" group, while scores >75th percentile classified children into the "hard texture likers" group.
The percentages of children classified as so-called 'soft texture likers' and 'hard texture likers' will be compared between groups.
Measured: from enrollment to the end of data collection (03.2026)
Secondary outcomes (2)
Comparison of the nutritional status of the study group and the control group based on percentile values for height, weight, and BMI.
Body weight (kg) and height (cm) values will be compared against percentile charts for the Polish population, and the resulting percentiles will be compared between groups. In addition, the data obtained will be expressed as the BMI index (kg/m²), which will likewise be compared against percentile charts, with the resulting percentiles then compared between groups.
For weight and BMI percentile values:
<5th percentile will be adopted as underweight, 5th-85th percentile as normal weight, >85th percentile as overweight, and >95th percentile as obesity.
Height percentiles will be divided into <5th percentile, indicating insufficient height, and values above this threshold, indicating adequate height.
Measured: from enrollment to the end of data collection (03.2026)
Comparison of percentage body fat content, based on skinfold thickness measurements, between the study group and the control group.
Based on skinfold thickness measurements (triceps and subscapular, expressed in mm), the percentage body fat content will be estimated using the Slaughter equation, and the resulting mean values will be compared between groups.
Measured: From enrollment to the end of data collection (03/2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start12 Apr 2023
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714226
- Sponsor's protocol ID
- KB 689/2022 i KB-242/2025
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gutierrez Martin M, Gomez Casal F. [Nitroblue-tetrazolium reduction and peroxidase activity in normal leukocytes (author's transl)]. Folia Clin Int (Barc). 1974 Mar;24(3):225-37. No abstract available. Spanish.
PubMed 4133288M. Laureati, P. Sandvik, V. L. Almli, M. Sandell, G.G. Zeinstra, L. Methven, M. Wallner, H. Jilani, B. Alfaro, C. Proserpio, Individual differences in texture preferences among European children: Development and validation of the Child Food Texture Preference Questionnaire (CFTPQ),Food Quality and Preference, Volume 80,2020,103828, https://doi.org/10.1016/j.foodqual.2019.103828.
Damsbo-Svendsen M, Frost MB, Olsen A. A review of instruments developed to measure food neophobia. Appetite. 2017 Jun 1;113:358-367. doi: 10.1016/j.appet.2017.02.032. Epub 2017 Mar 6.
PubMed 28268200Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.
PubMed 11693591Malczyk Z, Kuczka O, Pasztak-Opilka A, Zachurzok A. Validation of the Children's Eating Behaviour Questionnaire in Poland. Nutrients. 2022 Nov 11;14(22):4782. doi: 10.3390/nu14224782.
PubMed 36432467Ferraris C, Guglielmetti M, Pasca L, De Giorgis V, Ferraro OE, Brambilla I, Leone A, De Amicis R, Bertoli S, Veggiotti P, Tagliabue A. Impact of the Ketogenic Diet on Linear Growth in Children: A Single-Center Retrospective Analysis of 34 Cases. Nutrients. 2019 Jun 26;11(7):1442. doi: 10.3390/nu11071442.
PubMed 31247999Kossoff EH, Zupec-Kania BA, Auvin S, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Cross JH, Dahlin MG, Donner EJ, Guzel O, Jehle RS, Klepper J, Kang HC, Lambrechts DA, Liu YMC, Nathan JK, Nordli DR Jr, Pfeifer HH, Rho JM, Scheffer IE, Sharma S, Stafstrom CE, Thiele EA, Turner Z, Vaccarezza MM, van der Louw EJTM, Veggiotti P, Wheless JW, Wirrell EC; Charlie Foundation; Matthew's Friends; Practice Committee of the Child Neurology Society. Optimal clinical management of children receiving dietary therapies for epilepsy: Updated recommendations of the International Ketogenic Diet Study Group. Epilepsia Open. 2018 May 21;3(2):175-192. doi: 10.1002/epi4.12225. eCollection 2018 Jun.
PubMed 29881797