Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

January 9, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study participants will be drawn from among participants in the Johns Hopkins Adult Epilepsy Diet Center and Johns Hopkins Epilepsy Center who are age 18 or older, with body mass index (BMI) > 18.5, and on a stable antiepileptic drug regimen for > 1 month.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adults on Chronic ketogenic diets
Adults who have been on Modified Atkins or ketogenic diets for over 1 year
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.
Adults naive to ketogenic diets
Adults who have never been on Modified Atkins or ketogenic diets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound
Time Frame: 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.
Baseline and 12 months post diet implementation
Change in LDL fractions (nmol/L)
Time Frame: 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.
Baseline and 12 months post diet implementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in LDL fractions (nmol/L)
Time Frame: Baseline and 3 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 3 months of diet therapy.
Baseline and 3 months post diet implementation
Change in apolipoproteins (mg/dL)
Time Frame: Baseline and 3 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 3 months of diet therapy.
Baseline and 3 months post diet implementation
Change in apolipoproteins (mg/dL)
Time Frame: Baseline and 6 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 6 months of diet therapy.
Baseline and 6 months post diet implementation
Change in apolipoproteins (mg/dL)
Time Frame: Baseline and 12 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 12 months of diet therapy.
Baseline and 12 months post diet implementation
Change in apolipoproteins (mg/dL)
Time Frame: 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.
Baseline and 24 months post diet implementation
Change in LDL fractions (nmol/L)
Time Frame: Baseline and 6 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 6 months of diet therapy.
Baseline and 6 months post diet implementation
Change in LDL fractions (nmol/L)
Time Frame: 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.
Baseline and 24 months post diet implementation
Change in carotid artery intima-media thickness (mm) measured by carotid artery
Time Frame: 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.
Baseline and 24 months post diet implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mackenzie C Cervenka, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00070557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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