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

NCT ID: NCT06432231

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-28
• Study Completion Date: 2024-02-20

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low glycemic index diet treatment

Children with drug-resistant epilepsy were treated with a low glycemic index diet for 3 months.

Group Type: EXPERIMENTAL

Low glycemic index diet treatment

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

LGID

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Yurtdaş Depboylu

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gamze Yurtdaş Depboylu

Çiğli, İ̇zmi̇r, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-GAP-SABF-0052

Identifier Type: -

Identifier Source: org_study_id