Low-Glycemic Diet for Epilepsy

Overseen By Regan J Lemley, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Functional neurologic disorder, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low glycemic index diet, which emphasizes foods that slowly raise blood sugar, benefits pregnant individuals with epilepsy. Researchers aim to determine if this diet is easy to adhere to, reduces seizure frequency, and affects gut bacteria. Participants will be compared to those on a standard diet to identify any differences. Pregnant individuals up to 20 weeks into pregnancy with epilepsy may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on epilepsy during pregnancy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the low glycemic index diet is safe for pregnant people with epilepsy?

Research has shown that the low glycemic index diet (LGID) is generally safe and easy to follow. In past studies, many patients experienced fewer seizures while on this diet, with only a few side effects reported. For example, one study found that 65.2% of participants had more than a 50% reduction in seizures with this diet. Another study showed similar seizure reductions compared to other diets, such as the ketogenic diet and the modified Atkins diet. Overall, these findings suggest that the LGID is both effective and manageable for patients, with few negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard epilepsy treatments that often rely on medications like anti-seizure drugs, the low glycemic index diet offers a dietary approach to manage the condition. This diet is unique because it focuses on consuming foods that have a low impact on blood sugar levels, potentially reducing seizure frequency and severity. Researchers are excited about this treatment because it offers a non-pharmaceutical option, which could be particularly beneficial for patients who experience side effects from traditional medications or for those seeking a more natural approach to managing epilepsy.

What evidence suggests that the Low Glycemic Index Diet might be an effective treatment for epilepsy?

Research has shown that a diet with a low glycemic index can help reduce seizures in people with epilepsy. In one study, 65.2% of participants on this diet experienced their seizures drop by more than half. Another study found that 6 out of 20 children had a significant reduction in seizures with this diet, while none in the group not on the diet did. Overall, studies indicate that this diet can greatly reduce the number of seizures, making it a promising option for managing epilepsy. In this trial, participants in the Low Glycemic Index Diet Group will follow this diet with ongoing dietician support, while those in the Standard Diet Group will continue with their usual diet. These findings suggest the low glycemic index diet could also help pregnant people with epilepsy. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with epilepsy. Participants will be following a low glycemic index diet and providing stool and blood samples up to three times during the study. The trial excludes those not willing to adhere to the dietary plan or unable to provide samples as required.

Inclusion Criteria

Pregnant up to 20 weeks gestational age

I have been diagnosed with epilepsy.

Exclusion Criteria

I have diabetes.

I have taken antibiotics in the last 3 months.

I have not had any seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants start the low glycemic index diet with ongoing dietician support and food questionnaires until pregnancy completion

Until pregnancy completion

Regular dietician appointments

Sample Collection

Participants provide stool and blood samples during pregnancy and up to 3 months postpartum

During pregnancy and up to 3 months postpartum

Maximum 3 sample collections

Follow-up

Participants are monitored for seizure frequency, gut bacteria composition, and metabolic pathway alterations

3 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Low Glycemic Index Diet

Trial Overview Researchers are testing if a low glycemic index diet is tolerable, can change seizure frequency, and affect gut bacteria in pregnant people with epilepsy. They'll compare results from participants on this diet against those who aren't following any structured diet plan.

How Is the Trial Designed?

Group I: Low Glycemic Index Diet Group Experimental Treatment 1 Intervention

A low glycemic index diet will be started with ongoing dietician support \& food questionnaires until pregnancy completion.

Group II: Standard Diet Group Active Control 1 Intervention

A standard diet, as chosen by participants, will be followed with ongoing food questionnaires until pregnancy completion.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Epilepsy Foundation

Collaborator

Trials

12

Recruited

620+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38422595/

The efficacy of low glycemic index diet on seizure ... This systematic review and meta-analysis suggests that the low glycemia index diet can be beneficial as a treatment for epilepsy in pediatric patients.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33582533/

Efficacy of low glycemic index diet therapy (LGIT) in ... While 6/20 children in the LGIT arm have >50 % reduction in seizure frequency, none achieved this in the control arm (p = 0.02). The overall ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18292

Comparison of efficacy of low glycemic index treatment and ... In our study, 76.5% (13/17) of subjects with LGS in the MAD arm achieved >50% seizure reduction compared to 65.2% (15/23) in the LGIT arm, at 24 ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2769074

Efficacy of Ketogenic Diet, Modified Atkins Diet, and Low ... The data from this study show that all 3 dietary regimens—KD, MAD, and LGIT diet—significantly reduce the seizure burden in children with drug- ...

5. cureepilepsy.org cureepilepsy.org/news/comparison-of-the-ketogenic-diet-modified-atkins-diet-and-low-glycemic-index-therapy-diet-among-children-with-drug-resistant-epilepsy/

Comparison of the Ketogenic Diet, Modified Atkins ... Conclusions: Data from this study showed that all 3 dietary regimens – KD, MAD, and the LGIT diet – significantly reduce seizure burden.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1059131124000505

Review The efficacy of low glycemic index diet on seizure ... This systematic review and meta-analysis suggests that the low glycemia index diet can be beneficial as a treatment for epilepsy in pediatric patients.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7400196/

Efficacy of Ketogenic Diet, Modified Atkins Diet, and Low ... The median reduction in seizure burden was similar between the ketogenic diet, modified Atkins diet, and low glycemic index therapy diet.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19220406/

Efficacy, safety, and tolerability of the low glycemic index ... The LGIT was associated with reduced seizure frequency in a large fraction of patients, with limited side effects.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06432231

Effects of Low Glycemic Index Diet in Children With Drug ... LGID reduces seizure frequency in children with drug-resistant epilepsy. · LGID improves oxidative parameters in children with drug-resistant epilepsy · LGID ...