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

NCT04545346 | Completed

• 1 other identifier: IRB- 2019- 240
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change in seizure frequency

  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.

  At 1 month post treatment

• Change in seizure severity

  . 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).

  At 1 month post treatment

• Change in seizure duration

  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.

  At 1 month post treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Wait-listed control

NO INTERVENTION

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

Low Glutamate diet

EXPERIMENTAL

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.

Other: Low Glutamate diet

Interventions

Low Glutamate diet 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.

Low Glutamate diet

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• American University: lead
• Children's National Research Institute: collaborator

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (1)

• Sarlo GL, Kao A, Holton KF. Investigation of the low glutamate diet as an adjunct treatment for pediatric epilepsy: A pilot randomized controlled trial. Seizure. 2023 Mar;106:138-147. doi: 10.1016/j.seizure.2023.02.013. Epub 2023 Feb 20.

  PMID: 36867910 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kathleen Holton, MPH, PhD

  American University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 11, 2020
• Study Start: October 15, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)