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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.
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
At follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants
At follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults on Chronic ketogenic diets | Adults who have been on Modified Atkins or ketogenic diets for over 1 year |
| |
| Adults naive to ketogenic diets | Adults who have never been on Modified Atkins or ketogenic diets |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mackenzie C Cervenka, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33487129 | Derived | 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. |
| Label | URL |
|---|---|
| Ketogenic Diet Therapy for Epilepsy | View source |
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Blood samples
|
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 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| C563733 | Carotid Intimal Medial Thickness 1 |
| D012640 | Seizures |
| D004827 | Epilepsy |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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