An observational study in Epilepsy Intractable, sponsored by Wroclaw Medical University. Active, not recruiting at 2 sites in Poland. Open to participants aged 2 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Wroclaw Medical University · Observational
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.
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.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's planned enrollment of 150 is above the median of 88 across 40 observational studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.
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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.
Inclusion Criteria, studied group:
Exclusion Criteria, studied group :
Inclusion Criteria, control group:
Exclusion Criteria, control group:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from enrollment to the end of data collection (03.2026)
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.
Time frame: 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.
Time frame: From enrollment to the end of data collection (03/2026)
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Wroclaw Medical University