Testing a Diet Change and Statin to Lower Cholesterol in Adults With Epilepsy
Tests a diet change and atorvastatin to lower cholesterol in adults with epilepsy.
Plain-language title generated from the registry record
Registry title: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Key facts
- Where
- Baltimore, United StatesSee the site
- Phase
- Phase 1/2
Where in United States
- Johns Hopkins HospitalBaltimore, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT06369571
- Record updated
- 19 October 2026
- Original description
Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.Read full original descriptionShow less
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.
Inclusion: Modified Atkins Diet use ≥ 12 months; Dyslipidemia based on American College of Cardiology/American Heart Association guidelines (i.e., LDL ≥190 mg/dL, 10-year ASCVD risk ≥5% with risk enhancers, etc.); 18 years of age or older; Body mass index (BMI) > 18.5; Stable anti-seizure medication regimen for > 1 month.
Exclusion: Changes in anti-seizure medication regimen < 1 month prior to participation; Current statin medication use; Prior serious adverse response to atorvastatin or other statin medications; Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease); < 18 years of age; Body mass index (BMI) < 18.5; Uncorrected carnitine deficiency; Pregnancy.