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

21 Participants Needed

Trial Summary

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 data supports the effectiveness of the low glycemic index treatment for epilepsy?

Research shows that the low glycemic index treatment (LGIT) can help reduce seizures in people with epilepsy, with some studies reporting a 75-90% reduction in seizures for certain patients. It is considered a more tolerable and easier-to-implement alternative to the ketogenic diet, making it a viable first-line dietary therapy for epilepsy. ^{1 2 3 4 5}

Is the low-glycemic diet safe for humans?

The low-glycemic diet, used as a treatment for epilepsy, has been reported to be safe with no adverse events in studies involving children and young adults. It is considered more tolerable than the ketogenic diet, making it a viable dietary therapy option. ^{1 2 3 4 5}

How does the low glycemic index diet treatment differ from other treatments for epilepsy?

The low glycemic index diet (LGIT) is a less restrictive dietary treatment for epilepsy compared to the ketogenic diet, focusing on limiting carbohydrates to those that cause smaller increases in blood sugar. It is easier to follow and has shown similar effectiveness in reducing seizures, making it a viable first-line dietary therapy for those who find other diets too restrictive. ^{1 2 3 5 6}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Low glycemic index treatment in patients with drug-resistant epilepsy. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Low glycemic index diet in children and young adults with refractory epilepsy: first Italian experience. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Low glycemic index treatment for seizures in Angelman syndrome. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerability of the low glycemic index treatment in pediatric epilepsy. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Low glycemic index treatment: implementation and new insights into efficacy. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Glycemic index treatment using Japanese foods in a girl with Lennox-Gastaut syndrome. [2015]