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Enrolling by Invitation

NCT Number: NCT06369571

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • < 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

Treatment and study plan

Atorvastatin 10mg

Drug

Atorvastatin 10mg daily by mouth

Other names: Lipitor

Modification of dietary fat composition

Other

Replace 10% of saturated fat intake with polyunsaturated fat

Primary outcomes

  1. Diet adherence as assessed by 3 day food records

    Time frame: 12 weeks

    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.

  2. Statin Adherence

    Time frame: 12 weeks

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

  3. LDL Change

    Time frame: 12 weeks

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

  4. Change in weekly seizure frequency

    Time frame: 12 weeks

    12-week difference in weekly seizure frequency from baseline

  5. Seizure severity questionnaire score

    Time frame: 12 weeks

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

Secondary outcomes

  1. Frequency of adverse events

    Time frame: 12 weeks

    Frequency of adverse events

  2. Blood ketone change

    Time frame: 12 weeks

    12-week difference in serum beta-hydroxybutyrate level from baseline

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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