Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

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Johns Hopkins University

Status

Invitation-only

Conditions

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

Treatments

Dietary Supplement: Modified Atkins or Ketogenic Diet

Study type

Observational

Funder types

Other

Identifiers

NCT02694094
IRB00070557

Details and patient eligibility

About

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.

Full 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

Enrollment

105 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

105 participants in 2 patient groups

Adults on Chronic ketogenic diets
Description:
Adults who have been on Modified Atkins or ketogenic diets for over 1 year
Treatment:
Dietary Supplement: Modified Atkins or Ketogenic Diet
Adults naive to ketogenic diets
Description:
Adults who have never been on Modified Atkins or ketogenic diets

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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