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NCT Number: NCT02694094

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

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.

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Key information

Conditions

Hypercholesterolemia Brain Diseases Cardiovascular Disease Cardiovascular Diseases Carotid Intimal Medial Thickness 1 Central Nervous System Diseases Cerebrovascular Disease Cerebrovascular Disorders Coronary Disease Dyslipidemias Epilepsy Heart Disease Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Atkins or Ketogenic Diet

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Feb 29, 2016
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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