Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

January 12, 2024 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

Enrolling by invitation

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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

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
Intervention / Treatment
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

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

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

Johns Hopkins University

Investigators

  • 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

March 1, 2016

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimated)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00070557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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