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

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 5, 2024

Primary Completion Date

July 10, 2025

Study Completion Date

July 27, 2025

Conditions
SeizureEpilepsyDrug 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."

Trial Locations (1)

Unknown

Mashhad University of Medical Sciences, Mashhad

All Listed Sponsors
lead

Mashhad University of Medical Sciences

OTHER

NCT06703983 - Efficacy of Low Glycemic Index Diet Versus Classic Ketogenic Diet in Pediatric Epilepsy Treatment | Biotech Hunter | Biotech Hunter