EpilepsyNCT06175247
Low-Glycemic (LGI) Diet in Pregnant People With Epilepsy
A study testing Low Glycemic Index Diet in people with Epilepsy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are: Is the low glycemic index tolerable in pregnant people with epilepsy? Does the low glycemic index alter seizure frequency in pregnant people with epilepsy? Does the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Low Glycemic Index Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 1 Nov 2025
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy
- Pregnant up to 20 weeks gestational age
Who cannot join
- Functional neurologic disorder
- Primary gastrointestinal disease
- Antibiotic use in past 3 months
- Diabetes
- Seizure freedom
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Regan J Lemley, MD, 617-732-7432, rlemley@bwh.harvard.edu
About this study
The goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are:
- Is the low glycemic index tolerable in pregnant people with epilepsy?
- Does the low glycemic index alter seizure frequency in pregnant people with epilepsy?
- Does the low glycemic index alter the gut bacteria \& associated metabolic pathways in pregnant people with epilepsy? Participants will start the low glycemic index diet during pregnancy and will provide stool and blood samples a maximum of 3 times during study duration. Researchers will compare pregnant people with epilepsy on the diet to pregnant people with epilepsy not on a structured diet plan to see if tolerability, seizure frequency, and gut bacteria composition \& metabolites differ.
Read the detailed description
People with epilepsy who are planning for pregnancy or are pregnant have concerns about anti-seizure medication (ASM) treatment, as some ASMs increase the risk of major congenital malformations and can negatively influence cognitive outcomes in developing offspring (Tomson et al., 2018, Meador et al., 2021). Non-pharmacologic epilepsy treatments, such as specialized diets like the low glycemic diet or the modified Atkins diet, are not well studied in pregnant people with epilepsy but have proven to be effective in reducing seizures in the non-pregnant population. Dietary influence on seizure control is likely multifactorial, and recent studies have shown that one mechanism of action is to cause changes in the gut microbiome and alter neuroactive downstream bacterial metabolites, such as gamma-aminobutyric acid (Olson et al., 2018).
The low glycemic index (LGI) diet is one of the most flexible dietary therapies for epilepsy, and it appears to be safe in pregnancy with positive health outcomes for both the mother and baby (Walsh et al., 2012). Unfortunately, little is known about the effectiveness and mechanism of the LGI diet in pregnant patients with epilepsy. Therefore, the investigators propose this study in which the LGI diet will be initiated in the first half of pregnancy and explore LGI diet tolerability, seizure frequency, and potential underlying mechanisms in the pregnant epilepsy population.
Investigators will invite pregnant people with epilepsy up to 20 weeks gestation in the Brigham \& Women's Epilepsy-Obstetrical clinic to participate in this study. Participants will choose to go on the low glycemic index diet or continue their standard diet, will a goal of enrolling 21 participants in a 1:2 intervention to control group ratio. Participants in the intervention group will meet will a dietician to initiate the diet and have ongoing dietician support and appointments. All participants will fill out diet questionnaires and provide a maximum of 3 stool samples and 3 blood samples. Dietary intervention will end when pregnancies end, and stool and blood samples will be collected up to 3 months postpartum. The main outcomes will be diet tolerability, seizure frequency, gut bacteria composition, and metabolite alterations.
- Conditions
- Epilepsy
- Being tested
- Low Glycemic Index Diet
- Keywords
- low glycemic index diet, pregnancy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic Index DietOther
A low glycemic diet will be initiated with dietician support and guidance.
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Index Diet Group | Experimental | A low glycemic index diet will be started with ongoing dietician support \& food questionnaires until pregnancy completion. Receives: Other: Low Glycemic Index Diet |
| Standard Diet Group | No intervention | A standard diet, as chosen by participants, will be followed with ongoing food questionnaires until pregnancy completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the low glycemic index diet in pregnant people with epilepsy
Tolerability will be measured by the number of participants able to continue the diet in pregnancy with diet questionnaires + dietician follow up visits.
Measured: During the diet intervention and immediately after the diet intervention
Secondary outcomes (3)
Seizure Frequency
Seizure Frequency in the 9 months prior to pregnancy \& pre-enrollment will be determined via chart review, and seizures during pregnancy will be prospectively recorded. Pre-pregnancy and during pregnancy seizure frequencies will be compared.
Measured: Baseline pre-intervention, during the intervention, and through 3 months post-partum.
Gut Bacteria Composition
Stool samples will be collected during and after pregnancy (maximum 3 samples per participant) in participants in each study group (experimental group on the low glycemic index diet, control group on regular diet). Samples will be sequenced, metagenomic libraries will be constructed and Quantitative insights for microbial ecology 2 (QIIME2) will be used to examine the magnitude of group differences.
Measured: During the intervention until 3 months postpartum
Metabolic pathway alterations
Stool and blood samples will be collected during and after pregnancy (maximum 3 samples), metabolites will be identified, and metabolic pathway reconstruction will be performed to identify changes between participants in the experimental and control groups.
Measured: During the intervention until 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsy Foundation
- Responsible party
- Principal investigator, Regan J. Lemley, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175247
- Sponsor's protocol ID
- 2023P001868
- Status last verified
- Dec 2023
- First submitted
- 27 Oct 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Glycemic (LGI) Diet in Pregnant People With Epilepsy
- ClinicalTrials.gov ID
- NCT06175247
- Acronym / sponsor ID
- 2023P001868
- Conditions
- Epilepsy
- Keywords
- low glycemic index diet, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Epilepsy Foundation
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 18 Dec 2023 (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 goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are:
- Is the low glycemic index tolerable in pregnant people with epilepsy?
- Does the low glycemic index alter seizure frequency in pregnant people with epilepsy?
- Does the low glycemic index alter the gut bacteria \& associated metabolic pathways in pregnant people with epilepsy? Participants will start the low glycemic index diet during pregnancy and will provide stool and blood samples a maximum of 3 times during study duration. Researchers will compare pregnant people with epilepsy on the diet to pregnant people with epilepsy not on a structured diet plan to see if tolerability, seizure frequency, and gut bacteria composition \& metabolites differ.
Detailed description
People with epilepsy who are planning for pregnancy or are pregnant have concerns about anti-seizure medication (ASM) treatment, as some ASMs increase the risk of major congenital malformations and can negatively influence cognitive outcomes in developing offspring (Tomson et al., 2018, Meador et al., 2021). Non-pharmacologic epilepsy treatments, such as specialized diets like the low glycemic diet or the modified Atkins diet, are not well studied in pregnant people with epilepsy but have proven to be effective in reducing seizures in the non-pregnant population. Dietary influence on seizure control is likely multifactorial, and recent studies have shown that one mechanism of action is to cause changes in the gut microbiome and alter neuroactive downstream bacterial metabolites, such as gamma-aminobutyric acid (Olson et al., 2018).
The low glycemic index (LGI) diet is one of the most flexible dietary therapies for epilepsy, and it appears to be safe in pregnancy with positive health outcomes for both the mother and baby (Walsh et al., 2012). Unfortunately, little is known about the effectiveness and mechanism of the LGI diet in pregnant patients with epilepsy. Therefore, the investigators propose this study in which the LGI diet will be initiated in the first half of pregnancy and explore LGI diet tolerability, seizure frequency, and potential underlying mechanisms in the pregnant epilepsy population.
Investigators will invite pregnant people with epilepsy up to 20 weeks gestation in the Brigham \& Women's Epilepsy-Obstetrical clinic to participate in this study. Participants will choose to go on the low glycemic index diet or continue their standard diet, will a goal of enrolling 21 participants in a 1:2 intervention to control group ratio. Participants in the intervention group will meet will a dietician to initiate the diet and have ongoing dietician support and appointments. All participants will fill out diet questionnaires and provide a maximum of 3 stool samples and 3 blood samples. Dietary intervention will end when pregnancies end, and stool and blood samples will be collected up to 3 months postpartum. The main outcomes will be diet tolerability, seizure frequency, gut bacteria composition, and metabolite alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Index Diet Group | Experimental | Other: Low Glycemic Index DietA low glycemic index diet will be started with ongoing dietician support \& food questionnaires until pregnancy completion. |
| Standard Diet Group | No intervention | –A standard diet, as chosen by participants, will be followed with ongoing food questionnaires until pregnancy completion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy
- Pregnant up to 20 weeks gestational age
Key exclusion criteria (5 listed)
- Functional neurologic disorder
- Primary gastrointestinal disease
- Antibiotic use in past 3 months
- Diabetes
- Seizure freedom
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 Glycemic Index DietA low glycemic diet will be initiated with dietician support and guidance. | Other | Low Glycemic Index Diet Group |
Primary outcome
Tolerability of the low glycemic index diet in pregnant people with epilepsy
Time frame: During the diet intervention and immediately after the diet intervention
Tolerability will be measured by the number of participants able to continue the diet in pregnancy with diet questionnaires + dietician follow up visits.
3 secondary outcomes
Seizure Frequency
Time frame: Baseline pre-intervention, during the intervention, and through 3 months post-partum.
Gut Bacteria Composition
Time frame: During the intervention until 3 months postpartum
Metabolic pathway alterations
Time frame: During the intervention until 3 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- 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.
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 Glycemic Index Diet in people with Epilepsy, run by Brigham and Women's Hospital 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regan J Lemley, MD (6177327432, rlemley@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of the low glycemic index diet in pregnant people with epilepsy (time frame: During the diet intervention and immediately after the diet intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2023.