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

American University

Status: Completed

Conditions: Epilepsy in Youth; Diet Intervention; Randomized Controlled Trial; Refractory Epilepsy; Epilepsy in Children

Treatments: Other: Low Glutamate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04545346

IRB- 2019- 240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 4 or more seizures per month
• Willing to keep all medications constant during the study.
• All medications have remained constant for 30 days prior to study enrollment
• Any previously attempted dietary therapies stopped before study enrollment

Exclusion criteria

• Known or suspected inborn errors of metabolism
• Non-English speaking households

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Wait-listed control

No Intervention group

Description:

Participants continue care as usual. All all medications must be kept constant during the study period, unless medically necessary.

Low Glutamate diet

Experimental group

Description:

Participants are put on the low glutamate diet for one month. The low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake.

Treatment:

Other: Low Glutamate diet