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

NCT ID: NCT06369571

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

The scientific premise of this proposal is that established or long-term (≥ 12 months) Modified Atkins diet (MAD) use in AWE influences atherosclerotic cardiovascular disease (ASCVD) risk and can be modified to reduce dyslipidemia when observed. Hence, the overarching goals of this proposal are to explore the safety and feasibility of dyslipidemia management strategies to reduce ASCVD risk in AWE on MAD without increasing seizure risk. This study will collect data before and after randomly assigned interventions to reduce LDL in AWE on long-term MAD recruited from patients receiving clinical care in the Johns Hopkins Adult Epilepsy Diet Center.

AWE with dyslipidemia on long-term MAD will be randomized 1:1 to either MAD modification (10% reduction of dietary energy from saturated fat, replaced with poly-unsaturated fat ) or moderate-intensity statin use (atorvastatin 10mg) for 12 weeks.

Conditions

Epilepsy; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Statin

Participants will receive 10mg of atorvastatin daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Atorvastatin 10mg

Intervention Type: DRUG

Atorvastatin 10mg daily by mouth

Modified Atkins diet (MAD) Modification

Participants will be instructed on how to change their modified Atkins diet for 12 weeks. They will replace 10% of daily dietary energy from saturated fat with poly-unsaturated fat.

Group Type: EXPERIMENTAL

Modification of dietary fat composition

Intervention Type: OTHER

Replace 10% of saturated fat intake with polyunsaturated fat

Interventions

Atorvastatin 10mg

Atorvastatin 10mg daily by mouth

Intervention Type: DRUG

Modification of dietary fat composition

Replace 10% of saturated fat intake with polyunsaturated fat

Intervention Type: OTHER

Other Intervention Names

Lipitor

Eligibility Criteria

Inclusion Criteria

1. Modified Atkins Diet use ≥ 12 months

2. 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.)

3. 18 years of age or older

4. Body mass index (BMI) > 18.5

5. Stable anti-seizure medication regimen for > 1 month.

Exclusion Criteria

1. < 18 years of age

2. Body mass index (BMI) < 18.5

3. Changes in anti-seizure medication regimen < 1 month prior to participation

4. Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease)

5. Current statin medication use

6. Prior serious adverse response to atorvastatin or other statin medications

7. Uncorrected carnitine deficiency

8. Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanya J McDonald, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00439268

Identifier Type: -

Identifier Source: org_study_id