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

Overview

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.

Interventions

• Drug Atorvastatin 10mg
  Atorvastatin 10mg daily by mouth
• Other Modification of dietary fat composition
  Replace 10% of saturated fat intake with polyunsaturated fat

Primary outcome measures

• Diet adherence as assessed by 3 day food records [Time frame: 12 weeks]
• Statin Adherence [Time frame: 12 weeks]
• LDL Change [Time frame: 12 weeks]
• Change in weekly seizure frequency [Time frame: 12 weeks]
• Seizure severity questionnaire score [Time frame: 12 weeks]

Secondary outcome measures (2)

• Frequency of adverse events [Time frame: 12 weeks]
• Blood ketone change [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Johns Hopkins Hospital — Baltimore

Identifiers

NCT: NCT06369571 · IRB00439268

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗