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ENROLLING BY INVITATION
NCT06369571
PHASE1/PHASE2

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-10-04

Completion Date

2027-12

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin 10mg

Atorvastatin 10mg daily by mouth

OTHER

Modification of dietary fat composition

Replace 10% of saturated fat intake with polyunsaturated fat

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States