Efficacy of Low Glycemic Index Diet Versus Classic Ketogenic Diet in Pediatric Epilepsy Treatment

NCT06703983 | Completed DMC

• 1 other identifier: 4030150
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a common disease among children. Today, treating epilepsy remains a major challenge, with many children affected by this condition. According to reports, 30% of children with epilepsy do not respond well to treatment. Various methods are available for managing epilepsy, one of the most accepted therapies for this condition are dietary therapies. Numerous studies have shown that dietary therapy is an effective and can have reasonable response in treating seizure. The most commonly used dietary intervention is the Classic Ketogenic Diet (CKD). In the CKD, approximately 90% of calories come from fat, making it a highly restrictive regimen that causes significant challenges for children to follow. Many studies have reported low adherence rates due to its difficulty, with a substantial number of patients discontinuing the diet over time. Some studies have explored the use of the Low Glycemic Index Therapy(LGIT), another form of the ketogenic diet, in managing drug-resistant epilepsy can be successful. In the LGIT, 60% of energy is derived from fat, 30% from protein, and 10% from carbohydrates. Due to the reduced fat content and greater dietary flexibility, this diet has fewer side effects and is easier to follow. Studies have also shown higher adherence rates to LGIT compared to CKD. Although limited research is available on LGIT, existing studies suggest that it may be as effective as CKD in treating epilepsy. Given the widespread prevalence and severe complications associated with untreated epilepsy in children, Further research into dietary therapies is crucial, as untreated epilepsy can lead to irreversible damage in children. The aim of this study is to compare the effectiveness of the Low Glycemic Index therapy and the Classic Ketogenic Diet in epilepsy treatment. If LGIT proves to be as successful as CKD, it could be considered a suitable alternative for managing epilepsy. In this randomized clinical trial, 40 children with drug-resistant epilepsy will be enrolled. Participants will be selected from patients referred by Pediatric Neurologists to dietitians for ketogenic diet therapy. After obtaining informed consent, participants will be randomly assigned using a block randomization method to one of two groups: the LGIT group or the CKD group. At the end of three months, the two groups will be compared in terms of seizure frequency and duration using statistical tests. The effectiveness of LGIT relative to CKD will be reported.

Conditions

Seizure; Epilepsy; Drug Resistant Epilepsy

Keywords

Ketogenic diet; Classic ketogenic diet; Low glycemic index diet; LGIT; CKD; Refractory epilepsy; seizure; Drug resistant epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizure reduction

  This study consists of two arms: CKD , which has been the standard therapy for many years, and LGIT , a newer type of Ketogenic diet that has shown similar results to CKD in several published studies. This study aims to evaluate whether LGIT is as effective as CKD while offering a more comfortable and palatable dietary option. All 40 participants in both arms will recieve diet for 3 months.Parents will monitor and report the impact of the dietary therapy on seizure frequency, classifying outcomes into one of four categories: 1. Seizure free:No seizures reported 2. More than 90% seizure reduction 3. More than 50% seizure reduction 4. Less than 50% seizure reduction Based on previous studies, a reduction of less than 50% is considered an unsuccessful therapy for epilepsy treatment using dietary therapy. After three months, all 40 participants will be evaluated to determine the effectiveness of each diet in treating epilepsy and results will be analyzed.

  3 Months

Study Arms (2)

Classic Ketogenic diet

ACTIVE COMPARATOR

This study includes two arms, with participants allocated using a blocked randomization process. In the control arm, participants will follow the Classic Ketogenic Diet (CKD), a standard dietary therapy for epilepsy.The CKD is highly restrictive, with approximately 90% of total calories derived from fat, 6% from protein, and 4% from carbohydrates and this diet is really challenging for patients to follow. This arm will include 20 participants with drug-resistant epilepsy for whom the ketogenic diet has been asked by a pediatric neurologist and prescribed by a registered dietitian.Participants will be followed for three months, with parents documenting seizure frequency at each monthly follow-up visit. At the end of the study period, seizure outcomes will be analyzed and categorized into four groups: Seizure-free participants. Participants with \>90% seizure reduction. Participants with \>50% seizure reduction. Participants with \<50% seizure reduction (non-responders).

Other: Low Glycemic index therapy; Other: Classic Ketogenic Diet

Low glycemic index therapy

ACTIVE COMPARATOR

In intervention arm, patients will receive a low glycemic index diet(LGIT). The LGIT is a modified form of the ketogenic diet that restricts carbohydrate intake to sources with a glycemic index of less than 50. This diet provides approximately 60% of total calories from fat, 30% from protein, and 10% from carbohydrates.In the LGIT arm, there will be 20 participants who will follow a LGIT diet under the care of a Registered Dietitian and a Pediatric Neurologist. After three months, seizure outcomes will be categorized into the following groups: At the end of the study period, seizure outcomes will be analyzed and categorized into four groups: Seizure-free participants. Participants with \>90% seizure reduction. Participants with \>50% seizure reduction. Participants with \<50% seizure reduction (non-responders). Results will be analyzed and compared with Classic Ketogenic diet which serves as the standard dietary therapy for epilepsy.

Other: Low Glycemic index therapy; Other: Classic Ketogenic Diet

Interventions

Low Glycemic index therapy OTHER

In intervention arm, patients will receive a low glycemic index diet(LGIT). The LGIT is a modified form of the ketogenic diet that restricts carbohydrate intake to sources with a glycemic index of less than 50. This diet provides approximately 60% of total calories from fat, 30% from protein, and 10% from carbohydrates.In the LGIT arm, there will be 20 participants who will follow a LGIT diet under the care of a Registered Dietitian and a Pediatric Neurologist. After three months, seizure outcomes will be categorized into the following groups: At the end of the study period, seizure outcomes will be analyzed and categorized into four groups: Seizure-free participants. Participants with \>90% seizure reduction. Participants with \>50% seizure reduction. Participants with \<50% seizure reduction (non-responders). Results will be analyzed and compared with Classic Ketogenic diet which serves as the standard dietary therapy for epilepsy.

Also known as: LGIT

Classic Ketogenic diet; Low glycemic index therapy

Classic Ketogenic Diet OTHER

This study includes two interventions: Low Glycemic Index Therapy(LGIT) and Classic Ketogenic diet(CKD) with the CKD used as a comparison. There will have a total of 40 participants, randomly divided into two groups and each group would have 20 participants. The randomization process will use the block randomization technique and will be conducted via a website. Participants will first have a session with a pediatric neurologist and then meet with a Dietitian who will explain the ketogenic diet in detail for them. The participants in the CKD group will follow a Classic Ketogenic diet where 90% of calories come from fats, 6% from proteins, and 4% from carbohydrates. Patients receive the diet, and investigators will remain in online contact throughout the 3-month study, with monthly in-person visits for assessment and to ensure proper adherence to the diet. The primary outcome will be the reduction in seizures, as reported by the participants' parents.

Also known as: CKD

Classic Ketogenic diet; Low glycemic index therapy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children between 2 and 18 years old who still have epilepsy despite receiving 2 or more medications
• Children with genetic disease need to receive ketogenic diet (pyruvate dehydrogenase deficiency and GLUT-1 transporter deficiency)

You may not qualify if:

• Parents' disapproval of the child's participation in the study Having liver and kidney diseases Doctor's disapproval based on the patient's condition Absolute contraindications to the ketogenic diet

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Location

MeSH Terms

Conditions

Seizures; Epilepsy; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Saman Sepehrar (MSc Student in Nutrition), supervised by Dr. Talebi, Pediatrician, PhD in Nutrition.

Model Details: This study is an open-label randomized clinical trial with two arms: Low Glycemic Index therapy (LGIT) Classic Ketogenic Diet (CKD) Each arm will include 20 participants, allocated using a block randomization process. After three months, seizure reduction outcomes will be compared between the two groups. All 40 participants in both arms will recieve diet for 3 months.Parents will monitor and report the impact of the dietary therapy on seizure frequency, and each participant will be categorized into one of four groups based on the reported reduction: 1. Seizure free:No more seizures reported 2. More than 90% seizure reduction 3. More than 50% seizure reduction 4. Less than 50% seizure reduction Based on previous studies, a reduction of less than 50% is considered an unsuccessful therapy. After three months, all 40 participants will be evaluated to determine the effectiveness of each diet in treating epilepsy and results will be analyzed and reported.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: December 5, 2024
• Primary Completion: July 10, 2025
• Study Completion: July 27, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: starting in April 2025
• Access Criteria: The results will be released in an article.

Locations

IR (1)