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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06369571
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atorvastatin 10mg — DRUG
    Atorvastatin 10mg daily by mouth
  • Modification of dietary fat composition — OTHER
    Replace 10% of saturated fat intake with polyunsaturated fat

Study Details

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.

Key Dates

Start date
Oct 4, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Statin
    Participants will receive 10mg of atorvastatin daily for 12 weeks
  • Experimental: Modified Atkins diet (MAD) Modification
    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.

Primary Outcome Measure

Diet adherence as assessed by 3 day food records [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Johns Hopkins Hospital· Baltimore, MD

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