Epilepsy, Dyslipidemia
Conditions
Keywords
Modified Atkins Diet, Ketogenic Diet, Cholesterol
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.
Interventions
Atorvastatin 10mg daily by mouth
OTHERModification of dietary fat composition
Replace 10% of saturated fat intake with polyunsaturated fat
Sponsors
American Heart Association
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statin Adherence | 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. |
| Change in weekly seizure frequency | 12 weeks | 12-week difference in weekly seizure frequency from baseline |
| Seizure severity questionnaire score | 12 weeks | 12-week difference in seizure severity questionnaire (SSQ) score (score 1-7, with higher score indicating more severe seizures) |
| Diet adherence as assessed by 3 day food records | 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. |
| LDL Change | 12 weeks | 12-week % LDL change from baseline within arms and between arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood ketone change | 12 weeks | 12-week difference in serum beta-hydroxybutyrate level from baseline |
| Frequency of adverse events | 12 weeks | Frequency of adverse events |
Countries
United States
Outcome results
None listed