Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

NCT02694094 | Active Not Recruiting

• 1 other identifier: IRB00070557
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cholesterol; seizure; epilepsy; ketogenic; diet

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Change in LDL fractions (nmol/L)

  Baseline and 3 months post diet implementation

• Change in apolipoproteins (mg/dL)

  Baseline and 3 months post diet implementation

• Change in apolipoproteins (mg/dL)

  Baseline and 6 months post diet implementation

• Change in apolipoproteins (mg/dL)

  Baseline and 12 months post diet implementation

• Change in apolipoproteins (mg/dL)

  Baseline and 24 months post diet implementation

Study Arms (2)

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

Adults naive to ketogenic diets

Adults who have never been on Modified Atkins or ketogenic diets

Interventions

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.

Adults on Chronic ketogenic diets

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older
• Body mass index (BMI) \> 18.5
• Stable antiepileptic drug regimen for \> 1 month.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 33487129 DERIVED

Related Links

• Ketogenic Diet Therapy for Epilepsy

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

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

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Myocardial Ischemia

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mackenzie C Cervenka, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 29, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)