drugset / Trial / NCT06369571
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Phase 1/2
Enrolling by invitation
22 enrolled
Johns Hopkins University
American Heart Association · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2024-10-04
- Primary completion
- 2027-01
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Atorvastatin | Small molecule | 10 mg | Oral |