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

NCT07714226 | Active Not Recruiting

• 1 other identifier: KB 689/2022 i KB-242/2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Epilepsy Intractable

Keywords

ketogenic diet; drug resistance epilepsy; eating behaviours; RMR

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

  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.

  From enrollment to the end of data collection (03/2026)

Study Arms (2)

Study group - children with drug-resistant epilepsy on a ketogenic diet

Control group - healthy children on a standard diet

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• lack of consent from the child and guardians/caregivers to participate in the study
• non-adherence to ketogenic diet recommendations,
• % 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
• consent of the parent and child to participate in the study
• absence of chronic diseases, no permanent use of medications
• 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.
• lack of consent to perform/participate in the study
• chronic diseases including neurological disorders, certificates and/or diagnoses from a psychological-pedagogical counseling center
• chronic use of medications related to illness, inability to perform anthropometric measurements and RMR meaurements.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (2)

Dolnośląski Szpital Specjalistyczny im. T.Marciniaka

Wroclaw, Lower Silesian Voivodeship, Poland

Location

Wroclaw Medical University - Pharmacy Faculty

Wroclaw, Lower Silesian Voivodeship, Poland

Location

Related Publications (7)

• 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.

  PMID: 4133288 BACKGROUND

• M. 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.

  BACKGROUND

• 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.

  PMID: 28268200 BACKGROUND

• Wardle 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.

  PMID: 11693591 BACKGROUND

• Malczyk 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.

  PMID: 36432467 BACKGROUND

• Ferraris 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.

  PMID: 31247999 BACKGROUND

• Kossoff 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.

  PMID: 29881797 BACKGROUND

Related Links

• Charlie foundation - educational page about ketogenic diet
• Matthew's friends - educational page about ketogenic diet

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 20, 2026
• Study Start: April 12, 2023
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-06

Locations

PL (2)