The Potential of a Low Glutamate Diet in Refractory Pediatric Epilepsy Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in seizure frequency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Wait-listed control
Participants continue care as usual. All all medications must be kept constant during the study period, unless medically necessary.
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.
Intervention: Low Glutamate diet (Other)
Outcomes
Primary Outcomes
Change in seizure frequency
Time Frame: At 1 month post treatment
All families will keep a seizure diary recording the number of daily seizures. This will be used to accurately determine these variables for the last week, which will be recorded on seizure assessment forms.
Change in seizure severity
Time Frame: At 1 month post treatment
. During the last week of each study period, families will be asked to complete a seizure assessment form. This will include a subjective rating scale for seizure severity with a minimum score of 0 (not severe) and a maximum score of 10 (very severe).
Change in seizure duration
Time Frame: At 1 month post treatment
All families will keep a seizure diary recording the duration of seizures. This will be used to accurately determine these variables for the last week, which will be recorded on seizure assessment forms.
Secondary Outcomes
- The effect of a 1-month low-glutamate diet on quality of life in children with epilepsy.(At 1 month post treatment)
- The effect of a 1-month low-glutamate diet on cognitive functioning in children with epilepsy.(At 1 month post treatment)
- Examine change in resting state brain waves after 1-month on the low glutamate diet(At 1 month post treatment)
Investigators
Kathleen Holton
Associate Professor
American University