Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

NCT ID: NCT02694094

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2027-03-31

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults on Chronic ketogenic diets

Adults who have been on Modified Atkins or ketogenic diets for over 1 year

Modified Atkins or Ketogenic Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Adults naive to ketogenic diets

Adults who have never been on Modified Atkins or ketogenic diets

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mackenzie C Cervenka, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

McDonald TJW, Diaz-Arias L, Vizthum D, Henry-Barron BJ, Schlechter H, Kossoff EH, Cervenka MC. Six-month effects of modified Atkins diet implementation on indices of cardiovascular disease risk in adults with epilepsy. Nutr Neurosci. 2022 Jul;25(7):1548-1557. doi: 10.1080/1028415X.2021.1875301. Epub 2021 Jan 23.

Reference Type: DERIVED

PMID: 33487129 (View on PubMed)

Related Links

https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/epilepsy/diet-therapy.html

Ketogenic Diet Therapy for Epilepsy

Other Identifiers

IRB00070557

Identifier Type: -

Identifier Source: org_study_id