NCT02694094

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Conditions

• Hypercholesterolemia
• Carotid Intimal Medial Thickness 1
• Seizure
• Epilepsy
• Cardiovascular Disease
• Cerebrovascular Disease
• Heart Disease
• Coronary Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Modified Atkins or Ketogenic Diet	Biochemical and vascular parameters will be compared from adults who have been on ketogenic diet therapy for \> 12 months to adults naive to ketogenic diet therapy. In addition, adults naive to diet therapy who subsequently begin diet therapy will have these same parameters followed over time.

Timeline

• Start date: 2016-03-01
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2016-02-29
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States