Clinical trial NCT04545346: The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy
Official title: The Potential of a Low Glutamate Diet in Refractory Pediatric Epilepsy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy in Children
Epilepsy in Youth
Randomized Controlled Trial
Refractory Epilepsy
Diet Intervention
Lead sponsor: American University
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2020-09-11
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in seizure frequency
timeFrame: At 1 month post treatment
measure: Change in seizure severity
timeFrame: At 1 month post treatment
measure: Change in seizure duration
timeFrame: At 1 month post treatment
Secondary outcomes:
measure: The effect of a 1-month low-glutamate diet on quality of life in children with epilepsy.
timeFrame: At 1 month post treatment
measure: The effect of a 1-month low-glutamate diet on cognitive functioning in children with epilepsy.
timeFrame: At 1 month post treatment
measure: Examine change in resting state brain waves after 1-month on the low glutamate diet
timeFrame: At 1 month post treatment
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
affiliation: American University
name: Kathleen Holton, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: