Clinical Trials Directory

Trials / Completed

CompletedNCT06432231

Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Izmir Katip Celebi University · Academic / Other
Sex
All
Age
4 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLow glycemic index diet treatmentThis study was a non-randomized, single centre, pre/post-intervention study. A low glycemic index diet was prescribed by a dietician for 3 months. LGID treatment consisted of 10% (40-60 g) low glycaemic index (glycaemic index \<50) carbohydrate, 20-30% protein and 60-70% lipid

Timeline

Start date
2022-08-28
Primary completion
2024-02-20
Completion
2024-02-20
First posted
2024-05-29
Last updated
2024-05-29

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06432231. Inclusion in this directory is not an endorsement.