Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

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

Intervention / Treatment
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* Dietary Supplement: Modified Atkins or Ketogenic Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults on Chronic ketogenic diets<br>Adults who have been on Modified Atkins or ketogenic diets for over 1 year | Dietary Supplement: Modified Atkins or Ketogenic Diet<br>* 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.<br>|
| Adults naive to ketogenic diets<br>Adults who have never been on Modified Atkins or ketogenic diets | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 3 months of diet therapy. | Baseline and 3 months post diet implementation | 
| Change in apolipoproteins (mg/dL) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, seizure, epilepsy, ketogenic, diet