EpilepsyPhase 1/2NCT06369571
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet
A Phase 1/2 study testing Atorvastatin 10mg and Modification of dietary fat composition in people with Epilepsy and Dyslipidemia, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Dyslipidemia
- What is being tested?
- Atorvastatin 10mg and Modification of dietary fat composition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Epilepsy, Dyslipidemia
- Being tested
- Atorvastatin 10mg, Modification of dietary fat composition
- Keywords
- Modified Atkins Diet, Ketogenic Diet, Cholesterol
- Medical subject headings
- Epilepsy, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 10mgDrug
Also called Lipitor
Atorvastatin 10mg daily by mouth
Modification of dietary fat compositionOther
Replace 10% of saturated fat intake with polyunsaturated fat
| Study group | Role | What they receive |
|---|---|---|
| Statin | Active comparator | Participants will receive 10mg of atorvastatin daily for 12 weeks Receives: Drug: Atorvastatin 10mg |
| Modified Atkins diet (MAD) Modification | Experimental | Participants will be instructed on how to change their modified Atkins diet for 12 weeks. They will replace 10% of daily dietary energy from saturated fat with poly-unsaturated fat. Receives: Other: Modification of dietary fat composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet adherence as assessed by 3 day food records
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.
Measured: 12 weeks
Statin Adherence
Statin adherence will be determined based on pills returned at study completion, with participants labeled adherent if 80% or more of pills were consumed.
Measured: 12 weeks
LDL Change
12-week % LDL change from baseline within arms and between arms
Measured: 12 weeks
Change in weekly seizure frequency
12-week difference in weekly seizure frequency from baseline
Measured: 12 weeks
Seizure severity questionnaire score
12-week difference in seizure severity questionnaire (SSQ) score (score 1-7, with higher score indicating more severe seizures)
Measured: 12 weeks
Secondary outcomes (2)
Frequency of adverse events
Frequency of adverse events
Measured: 12 weeks
Blood ketone change
12-week difference in serum beta-hydroxybutyrate level from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start4 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Tanya J McDonald, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369571
- Sponsor's protocol ID
- IRB00439268
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No