NCT04545346

The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy

The Potential of a Low Glutamate Diet in Refractory Pediatric Epilepsy Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: American University · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The study is investigating if following the low glutamate diet for 1 month, as compared to care as usual, can improve seizure frequency, severity, and duration; cognitive functioning; and/or quality of life in children with epilepsy.

Detailed description

Epilepsy is estimated to effect 470,000 children within the U.S. About a third of epilepsy patients are refractory. For these patients, dietary therapy is an alternative option. However, current dietary therapies present issues with compliance, palatability, adverse events, and providing necessary nutrients for brain growth and development during childhood. A dietary option that can improve tolerability, increase compliance, and reduce or eliminate adverse effects, while also optimizing nutrient intake, is critical for the advancement of dietary therapy options in epilepsy. Glutamate is found in the diet as a flavor enhancer; and is also an important neurotransmitter in the body which mediates seizure activity. Dietary sources of free glutamate are common and include numerous food additives (including many hidden sources) and some items which naturally contain higher amounts of glutamate. The low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake, which can protect against the negative effects caused by high glutamate concentrations in the brain. Additionally, the low glutamate diet is balanced, nutritious and palatable, with no side effects. The study is investigating if following the low glutamate diet for 1 month can improve seizure frequency, severity, and duration; cognitive functioning; and/or quality of life, in children with epilepsy. Participation in the study will be done virtually and over a 2- or 3- month study period, depending on group randomization. All participants will have the opportunity to undergo dietary training and follow the diet.

Conditions

• Epilepsy in Children
• Epilepsy in Youth
• Randomized Controlled Trial
• Refractory Epilepsy
• Diet Intervention

Interventions

Type	Name	Description
OTHER	Low Glutamate diet	Participants will be given extensive online dietary training and assigned to follow the low glutamate diet for one month. The low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake.

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2020-09-11
• Last updated: 2022-07-20

Locations

1 site across 1 country: United States