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Completed

NCT Number: NCT06432231

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

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).

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Key information

Conditions

Ketogenic Diet Behavior Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases Oxidative Stress Personal Satisfaction Psychological Health Psychological Well-Being Quality of Life

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gamze Yurtdaş Depboylu

Çiğli, İ̇zmi̇r, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: LGID

Primary outcomes

  1. Changes in seizure frequency

    Time frame: Baseline and Month 3

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

  2. Concentration of antioxidant and oxidant status

    Time frame: Baseline and Month 3

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

  3. Concentration of Paraoxonase Enzyme Activity

    Time frame: Baseline and Month 3

    Measurement of Paraoxonase Enzyme Activity (PON-1)

  4. Concentration of Malondialdehyde (MDA)

    Time frame: Baseline and Month 3

    Measurement of Malondialdehyde (MDA)

  5. Changes in quality of life

    Time frame: Baseline and Month 3

    "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

  6. Changes in psychosocial problems

    Time frame: Baseline and Month 3

    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.

  7. Changes in depression level

    Time frame: Baseline and Month 3

    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.

Secondary outcomes

  1. Concentration of glucose

    Time frame: Baseline and Month 3

    Measurement of glucose

  2. Concentration of insulin

    Time frame: Baseline and Month 3

    Measurement of insulin

  3. Concentration of liver function tests

    Time frame: Baseline and Month 3

    Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST)

  4. Changes in lipid profile

    Time frame: Baseline and Month 3

    Measurement of total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), serum triglyceride (mg/dl)

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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