Ketogenic diet in kids with epilepsy: how does it affect eating habits and metabolism?

NCT ID NCT07714226

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
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First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This observational study compares eating behaviors—such as picky eating, food neophobia, and texture preferences—between children with drug-resistant epilepsy who follow a ketogenic diet and healthy children. Researchers also measure body composition and resting metabolic rate in both groups. The goal is to identify eating challenges that may affect diet quality and nutritional status in children on the ketogenic diet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketogenic diet
What this could lead to
If successful, this study could identify specific eating difficulties in children on a ketogenic diet, helping to improve diet adherence and nutritional care.
What could go wrong
This is an observational study, not a treatment trial, so it cannot prove cause and effect. Results may not apply to all children with epilepsy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

2 to 15 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dolnośląski Szpital Specjalistyczny im. T.Marciniaka

    Wroclaw, Lower Silesian Voivodeship, Poland

  • Wroclaw Medical University - Pharmacy Faculty

    Wroclaw, Lower Silesian Voivodeship, Poland

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