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

NCT06432231 | Completed

• 1 other identifier: 2022-GAP-SABF-0052
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Changes in seizure frequency

  Seizure diary was kept by parents to records seizure frequency and severity

  Baseline and Month 3

• Concentration of antioxidant and oxidant status

  Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS))

  Baseline and Month 3

• Concentration of Paraoxonase Enzyme Activity

  Measurement of Paraoxonase Enzyme Activity (PON-1)

  Baseline and Month 3

• Concentration of Malondialdehyde (MDA)

  Measurement of Malondialdehyde (MDA)

  Baseline and Month 3

• 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

• 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

• 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 Outcomes (4)

• Concentration of glucose

  Baseline and Month 3

• Concentration of insulin

  Baseline and Month 3

• Concentration of liver function tests

  Baseline and Month 3

• Changes in lipid profile

  Baseline and Month 3

Study Arms (1)

Low glycemic index diet treatment

EXPERIMENTAL

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

Other: Low glycemic index diet treatment

Interventions

Low glycemic index diet treatment 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

Also known as: LGID

Low glycemic index diet treatment

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Gamze Yurtdaş Depboylu

Çiğli, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Psychological Well-Being

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 29, 2024
• Study Start: August 28, 2022
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

TU (1)