Low-Glycemic (LGI) Diet in Pregnant People With Epilepsy

NCT06175247 | Unknown

• 1 other identifier: 2023P001868
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Epilepsy

Keywords

low glycemic index diet; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  During the diet intervention and immediately after the diet intervention

Secondary Outcomes (3)

• Seizure Frequency

  Baseline pre-intervention, during the intervention, and through 3 months post-partum.

• Gut Bacteria Composition

  During the intervention until 3 months postpartum

• Metabolic pathway alterations

  During the intervention until 3 months postpartum

Study Arms (2)

Low Glycemic Index Diet Group

EXPERIMENTAL

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

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.

Interventions

Low Glycemic Index Diet OTHER

A low glycemic diet will be initiated with dietician support and guidance.

Low Glycemic Index Diet Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility is based on gestational potential.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy
• Pregnant up to 20 weeks gestational age

You may not qualify if:

• Functional neurologic disorder
• Primary gastrointestinal disease
• Antibiotic use in past 3 months
• Diabetes
• Seizure freedom

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Epilepsy Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Regan J Lemley, MD

CONTACT

6177327432; rlemley@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Neurology, Division of Epilepsy

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: December 18, 2023
• Study Start: December 15, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)