NCT06369571Enrolling by invitationPhase 1/2
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 12 Apr 2024
- Start date
- Oct 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Epilepsy
- NCT number
- NCT06369571
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 22
- From Oct 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Changes in anti-seizure medication regimen \< 1 month prior to participation
- Current statin medication use
- Prior serious adverse response to atorvastatin or other statin medications
Other illness
- Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease)
Age
- \< 18 years of age
Other
- Body mass index (BMI) \< 18.5
- Uncorrected carnitine deficiency
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.