## Protocol Section
### Identification Module
**NCT ID:** NCT06432231

**Brief Title:** Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy

**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

#### Organization Study ID Info
**ID:** 2022-GAP-SABF-0052
#### Organization
**Class:** OTHER
**Full Name:** Izmir Katip Celebi University
### Status Module
#### Completion Date
**Date:** 2024-02-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Izmir Katip Celebi University

#### Responsible Party

**Investigator Affiliation:** Izmir Katip Celebi University

**Investigator Full Name:** Gamze Yurtdaş Depboylu

**Investigator Title:** Associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Ketogenic Diet

- Drug Resistant Epilepsy

- Oxidative Stress

- Quality of Life

- Psychological Health

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Low glycemic index diet treatment

**Label:** Low glycemic index diet treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Low glycemic index diet treatment

**Description:** 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

**Name:** Low glycemic index diet treatment

**Other Names:**

- LGID

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Changes in seizure frequency

**Time Frame:** Baseline and Month 3

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

**Measure:** Concentration of antioxidant and oxidant status

**Time Frame:** Baseline and Month 3

**Description:** Measurement of Paraoxonase Enzyme Activity (PON-1)

**Measure:** Concentration of Paraoxonase Enzyme Activity

**Time Frame:** Baseline and Month 3

**Description:** Measurement of Malondialdehyde (MDA)

**Measure:** Concentration of Malondialdehyde (MDA)

**Time Frame:** Baseline and Month 3

**Description:** "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

**Measure:** Changes in quality of life

**Time Frame:** Baseline and Month 3

**Description:** 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.

**Measure:** Changes in psychosocial problems

**Time Frame:** Baseline and Month 3

**Description:** 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.

**Measure:** Changes in depression level

**Time Frame:** Baseline and Month 3

#### Secondary Outcomes

**Description:** Measurement of glucose

**Measure:** Concentration of glucose

**Time Frame:** Baseline and Month 3

**Description:** Measurement of insulin

**Measure:** Concentration of insulin

**Time Frame:** Baseline and Month 3

**Description:** Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST)

**Measure:** Concentration of liver function tests

**Time Frame:** Baseline and Month 3

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

**Measure:** Changes in lipid profile

**Time Frame:** Baseline and Month 3

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Çi̇ğli̇

**Country:** Turkey

**Facility:** Gamze Yurtdaş Depboylu

**State:** İ̇zmi̇r

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M7983

- Name: Epilepsy

- Relevance: HIGH

- As Found: Epilepsy

- ID: M369

- Name: Drug Resistant Epilepsy

- Relevance: HIGH

- As Found: Drug Resistant Epilepsy

- ID: M15452

- Name: Seizures

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000004827

- Term: Epilepsy

- ID: D000069279

- Term: Drug Resistant Epilepsy

### Misc Info Module

- Version Holder: 2024-05-31
