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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-06-15

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wait-listed control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Low Glutamate diet

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.

Group Type EXPERIMENTAL

Low Glutamate diet

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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