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Active Not Recruiting NCT07714226

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

Conditions: Epilepsy Intractable

Sex: All
Ages: 2 Years – 15 Years
Healthy volunteers: Yes
Enrollment: 150
Sponsor: Wroclaw Medical University

Location: Dolnośląski Szpital Specjalistyczny im. T.Marciniaka Wroclaw Lower Silesian Voivodeship

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.

Eligibility Criteria

Inclusion Criteria, studied group: * 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 Exclusion Criteria, studied group : * 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 Inclusion Criteria, control group: * 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. Exclusion Criteria, control group: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07714226). StuddyBuddy aggregates publicly available trial information.