40
Participants
Start Date
December 5, 2024
Primary Completion Date
July 10, 2025
Study Completion Date
July 27, 2025
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.
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."
Mashhad University of Medical Sciences, Mashhad
Mashhad University of Medical Sciences
OTHER