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

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

Interventions

OTHER

Low Glycemic index therapy

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

Classic Ketogenic Diet

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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-05

Primary Completion

2025-07-10

Completion

2025-07-27

Countries

• Iran

Study Locations