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

NCT06369571 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: IRB00439268
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Dyslipidemia

Keywords

Modified Atkins Diet; Ketogenic Diet; Cholesterol

Outcome Measures

Primary Outcomes (5)

• Diet adherence as assessed by 3 day food records

  Diet adherence will be based on the ability to achieve 10% reduction in dietary energy from saturated fat assessed from 3-day food records, the gold standard for diet intake assessments.

  12 weeks

• Statin Adherence

  Statin adherence will be determined based on pills returned at study completion, with participants labeled adherent if 80% or more of pills were consumed.

  12 weeks

• LDL Change

  12-week % LDL change from baseline within arms and between arms

  12 weeks

• Change in weekly seizure frequency

  12-week difference in weekly seizure frequency from baseline

  12 weeks

• Seizure severity questionnaire score

  12-week difference in seizure severity questionnaire (SSQ) score (score 1-7, with higher score indicating more severe seizures)

  12 weeks

Secondary Outcomes (2)

• Frequency of adverse events

  12 weeks

• Blood ketone change

  12 weeks

Study Arms (2)

Statin

ACTIVE COMPARATOR

Participants will receive 10mg of atorvastatin daily for 12 weeks

Drug: Atorvastatin 10mg

Modified Atkins diet (MAD) Modification

EXPERIMENTAL

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.

Other: Modification of dietary fat composition

Interventions

Atorvastatin 10mg DRUG

Atorvastatin 10mg daily by mouth

Also known as: Lipitor

Statin

Modification of dietary fat composition OTHER

Replace 10% of saturated fat intake with polyunsaturated fat

Modified Atkins diet (MAD) Modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• years of age or older
• Body mass index (BMI) \> 18.5
• Stable anti-seizure medication regimen for \> 1 month.

You may not qualify if:

• \< 18 years of age
• Body mass index (BMI) \< 18.5
• Changes in anti-seizure medication regimen \< 1 month prior to participation
• Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease)
• Current statin medication use
• Prior serious adverse response to atorvastatin or other statin medications
• Uncorrected carnitine deficiency
• Pregnancy

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Heart Association: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Epilepsy; Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Tanya J McDonald, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)