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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06432231
• Other study ID #: 2022-GAP-SABF-0052
• Status: Completed
• Phase: N/A
• Start date: August 28, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: May 2024
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Ketogenic Diet
• Oxidative Stress
• Psychological Health
• Quality of Life

Intervention

Other:
• Low glycemic index diet treatment
This 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

Locations

Country	Name	City	State
Turkey	Gamze Yurtdas Depboylu	Çi?gli?	I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in seizure frequency	Seizure diary was kept by parents to records seizure frequency and severity	Baseline and Month 3
Primary	Concentration of antioxidant and oxidant status	Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS))	Baseline and Month 3
Primary	Concentration of Paraoxonase Enzyme Activity	Measurement of Paraoxonase Enzyme Activity (PON-1)	Baseline and Month 3
Primary	Concentration of Malondialdehyde (MDA)	Measurement of Malondialdehyde (MDA)	Baseline and Month 3
Primary	Changes in quality of life	"Pediatric Inventory of Quality of Life" was applied to assess health-related quality of life. A higher score corresponds to a higher health-related quality of life. The score ranges from 0 to 100	Baseline and Month 3
Primary	Changes in psychosocial problems	Psychosocial problems were assessed by the "Strengths and Difficulties Questionnaire".The questionnaire includes 25 questions, some of which question positive and some of which question negative behavioral characteristics. These questions are grouped under 5 sub-headings. These are behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems and social behaviors. Each heading is evaluated in itself with scores that range from 0 to 10 and the sum of the first four headings gives the "total difficulty score". While high scores in social behavior reflect the individual's strengths in the social domain, high scores in the other four domains (behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems) reflect that the problem areas are severe.	Baseline and Month 3
Primary	Changes in depression level	Depression status was assessed by the "Children's Depression Scale".Scores that can be obtained from the scale can vary between 0-54. The cut-off point of the depression scale for children is 19, and high scores indicate a high risk of depression.	Baseline and Month 3
Secondary	Concentration of glucose	Measurement of glucose	Baseline and Month 3
Secondary	Concentration of insulin	Measurement of insulin	Baseline and Month 3
Secondary	Concentration of liver function tests	Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST)	Baseline and Month 3
Secondary	Changes in lipid profile	Measurement of total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), serum triglyceride (mg/dl)	Baseline and Month 3