Clinical trial NCT06432231: Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy
Official title: The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency, Oxidative Stress, Mental Health, and Health-related Quality of Life in Children With Drug-resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogenic Diet
Drug Resistant Epilepsy
Oxidative Stress
Quality of Life
Psychological Health
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (LGID) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. Based upon the aims, the following hypotheses were tested:

1. LGID reduces seizure frequency in children with drug-resistant epilepsy.
2. LGID improves oxidative parameters in children with drug-resistant epilepsy
3. LGID improves quality of life and mental health in children with drug-resistant epilepsy

Participants were prescribed the LGID for 3 months.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements were collected. Diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months).

Detailed description: The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.This study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. Low glycemic index diet was started on an out-patient basis. Children and their parents were educated about the diet and the effect of the diet on seizures. Children who were willing to follow the diet were included in the study. The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. Parents were asked to record the seizure frequency and severity in a seizure diary.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 4-18,
* being diagnosed with drug-resistant epilepsy,
* having more than one seizure per week,
* not having followed a ketogenic diet before.
* willing to come for regular follow up

Exclusion Criteria:

* children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.
* non-compliance with the diet recommended by the patient and/or parents
* enteral tube or parenteral feeding

Primary outcomes:
measure: Changes in seizure frequency
timeFrame: Baseline and Month 3
measure: Concentration of antioxidant and oxidant status
timeFrame: Baseline and Month 3
measure: Concentration of Paraoxonase Enzyme Activity
timeFrame: Baseline and Month 3
measure: Concentration of Malondialdehyde (MDA)
timeFrame: Baseline and Month 3
measure: Changes in quality of life
timeFrame: Baseline and Month 3
measure: Changes in psychosocial problems
timeFrame: Baseline and Month 3
measure: Changes in depression level
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: Concentration of glucose
timeFrame: Baseline and Month 3
measure: Concentration of insulin
timeFrame: Baseline and Month 3
measure: Concentration of liver function tests
timeFrame: Baseline and Month 3
measure: Changes in lipid profile
timeFrame: Baseline and Month 3
Other outcomes:
Locations:
city: Çi̇ğli̇
country: Turkey
facility: Gamze Yurtdaş Depboylu
state: İ̇zmi̇r
Study officials:
References: