Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Active, not recruiting

• Conditions: Hypercholesterolemia; Heart Disease; Seizure; Cerebrovascular Disease; Cardiovascular Disease; Epilepsy; Coronary Disease; Carotid Intimal Medial Thickness 1
• Interventions: Dietary Supplement: Modified Atkins or Ketogenic Diet

• Registration Number: NCT02694094
• Lead Sponsor: Johns Hopkins University

Brief Summary

This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.

Detailed Description

If participants agree to be in this study, the investigators will ask the participants to do the following things:

At Initial enrollment for both longterm ketogenic diet and new modified Atkins diet participants

* Review of calendars (showing seizures) and 3-day food record

* Check height and weight, blood pressure, skin-fold thickness and waist circumference

* Standard modified Atkins diet clinic labs will be drawn as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1

* Participant will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of enrollment or within 1 month of enrollment

At follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants

* Review of calendars and food records

* Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1

* Check height and weight, blood pressure, skin-fold thickness and waist circumference

At follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants

* Review of calendars and food records

* Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1

* Check height and weight, blood pressure, skin-fold thickness and waist circumference

* Participants will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of follow-up or within 1 month of follow-up

Study Timeline

• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Study Start: 2016-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• 18 years of age or older
• Body mass index (BMI) > 18.5
• Stable antiepileptic drug regimen for > 1 month.

Exclusion Criteria

• < 18 years of age
• Body mass index (BMI) < 18.5
• Changes in antiepileptic drug regimen < 1 month prior to participation
• Previous cardiovascular event or treatment ((including myocardial infarction, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI))
• Acute pancreatitis
• Unwilling to restrict carbohydrates
• Kidney disease
• Contraindicated metabolic or mitochondrial disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults on Chronic ketogenic diets	Modified Atkins or Ketogenic Diet	Adults who have been on Modified Atkins or ketogenic diets for over 1 year

Primary Outcome Measures

Name	Time	Method
Change in LDL fractions (nmol/L)	Baseline and 12 months post diet implementation	The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 12 months of diet therapy.
Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound	Baseline and 12 months post diet implementation	Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 12 months of diet therapy.

Secondary Outcome Measures

Name	Time	Method
Change in carotid artery intima-media thickness (mm) measured by carotid artery	Baseline and 24 months post diet implementation	Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 24 months of diet therapy.
Change in LDL fractions (nmol/L)	Baseline and 24 months post diet implementation	The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 24 months of diet therapy.
Change in apolipoproteins (mg/dL)	Baseline and 24 months post diet implementation	The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 24 months of diet therapy.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States