drugset / Trial / NCT06369571

Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet

NCT06369571

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

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 10 mg Oral

Indications