Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
NCT Number: NCT06369571
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Baltimore, Maryland, 21287, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atorvastatin 10mg daily by mouth
Other names: Lipitor
Replace 10% of saturated fat intake with polyunsaturated fat
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.
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.
Time frame: 12 weeks
12-week % LDL change from baseline within arms and between arms
Time frame: 12 weeks
12-week difference in weekly seizure frequency from baseline
Time frame: 12 weeks
12-week difference in seizure severity questionnaire (SSQ) score (score 1-7, with higher score indicating more severe seizures)
Time frame: 12 weeks
Frequency of adverse events
Time frame: 12 weeks
12-week difference in serum beta-hydroxybutyrate level from baseline
Johns Hopkins University
Other
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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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