Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Epilepsy Clinical Trial

Official title:

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02694094
• Other study ID #: IRB00070557
• Status: Enrolling by invitation
• Start date: March 2016
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 105
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound	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.	Baseline and 12 months post diet implementation
Primary	Change in LDL fractions (nmol/L)	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.	Baseline and 12 months post diet implementation
Secondary	Change in LDL fractions (nmol/L)	The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 3 months of diet therapy.	Baseline and 3 months post diet implementation
Secondary	Change in apolipoproteins (mg/dL)	The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 3 months of diet therapy.	Baseline and 3 months post diet implementation
Secondary	Change in apolipoproteins (mg/dL)	The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 6 months of diet therapy.	Baseline and 6 months post diet implementation
Secondary	Change in apolipoproteins (mg/dL)	The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 12 months of diet therapy.	Baseline and 12 months post diet implementation
Secondary	Change in apolipoproteins (mg/dL)	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.	Baseline and 24 months post diet implementation
Secondary	Change in LDL fractions (nmol/L)	The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 6 months of diet therapy.	Baseline and 6 months post diet implementation
Secondary	Change in LDL fractions (nmol/L)	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.	Baseline and 24 months post diet implementation
Secondary	Change in carotid artery intima-media thickness (mm) measured by carotid artery	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.	Baseline and 24 months post diet implementation

External Links

•   Ketogenic Diet Therapy for Epilepsy