Epilepsy in ChildrenNCT04545346
The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy
A study testing Low Glutamate diet in people with Epilepsy in Children and Epilepsy in Youth, run by American University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Epilepsy in Children, Epilepsy in Youth, Randomized Controlled Trial
- What is being tested?
- Low Glutamate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Known or suspected inborn errors of metabolism
- Non-English speaking households
Trial locations and contacts
1 site in 1 country.
United States1 site
American University
Washington D.C., District of Columbia, 20016
About this study
Official title: The Potential of a Low Glutamate Diet in Refractory Pediatric Epilepsy Patients
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.
Read the 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.
- Conditions
- Epilepsy in Children, Epilepsy in Youth, Randomized Controlled Trial, Refractory Epilepsy, Diet Intervention
- Being tested
- Low Glutamate diet
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glutamate dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Low Glutamate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Parents will be asked to complete the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55). This 55-question quality of life questionnaire has been validated for children ages 4 and older and is used to assess the participant's cognitive, emotional, social, and physical functioning.
Measured: At 1 month post treatment
The effect of a 1-month low-glutamate diet on cognitive functioning in children with epilepsy.
Cognitive function will be assessed via CNSVS, a computerized neurocognitive testing software.
Measured: At 1 month post treatment
Examine change in resting state brain waves after 1-month on the low glutamate diet
Electroencephalography (EEG) will be offered to all participants. Four minutes of eyes-closed and eyes-open resting state EEG data will be recorded at the end of the baseline, wait-listed control, and active intervention periods in a sound-attenuated, air-conditioned room. Participants will sit in a comfortable chair in front of a computer monitor. For eyes-closed recordings, participants will be instructed to sit as still as possible, while staying relaxed but awake. For eyes-open recordings, participants will be instructed to sit as still as possible and to focus on a fixation point on the screen while keeping blinking to a minimum, if possible. Participants will be monitored to make sure they are complying with condition instructions. Mean power (total power of frequency band/width of frequency band) and relative power (absolute power of frequency band/total power or percent) will be calculated for delta, theta, alpha, beta, gamma, high gamma, and total power.
Measured: At 1 month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start15 Oct 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Principal investigator, Kathleen Holton, American University
- Investigators
- Kathleen Holton, MPH, PhD, Principal investigator, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545346
- Sponsor's protocol ID
- IRB- 2019- 240
- Status last verified
- Jul 2022
- First submitted
- 26 Aug 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36867910
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of a Low Glutamate Diet in Refractory Pediatric Epilepsy Patients
- ClinicalTrials.gov ID
- NCT04545346
- Acronym / sponsor ID
- IRB- 2019- 240
- Conditions
- Epilepsy in Children, Epilepsy in Youth, Randomized Controlled Trial, Refractory Epilepsy, Diet Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Low Glutamate dietParticipants 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. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Known or suspected inborn errors of metabolism
- Non-English speaking households
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glutamate dietParticipants 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. | Other | Low Glutamate diet |
Primary outcome
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.
3 secondary outcomes
The effect of a 1-month low-glutamate diet on quality of life in children with epilepsy.
Time frame: At 1 month post treatment
The effect of a 1-month low-glutamate diet on cognitive functioning in children with epilepsy.
Time frame: At 1 month post treatment
Examine change in resting state brain waves after 1-month on the low glutamate diet
Time frame: At 1 month post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 36867910Sarlo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Holton, MPH, PhD principal investigator
American University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glutamate diet in people with Epilepsy in Children and Epilepsy in Youth, run by American University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seizure frequency (time frame: At 1 month post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.