Status:
RECRUITING
Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
Lead Sponsor:
Washington University School of Medicine
Conditions:
Hypercholesterolemia and Hyperlipidemia
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-...
Detailed Description
This study will evaluate the mechanism of ketogenic diet-induced hypercholesterolemia in susceptible normal-weight adults. The first stage of screening will identify eligible young adults who are norm...
Eligibility Criteria
Inclusion
- age ≥ 18 and \< 40 years
- BMI ≥ 18.5 and \< 25.0 kg/m2
- baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
- baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
- HbA1c ≤ 5.6%.
Exclusion
- personal or family history of familial hypercholesterolemia
- current use of lipid-lowering drugs
- currently on a ketogenic diet and unwilling to change diet
- current tobacco use
- hypertension
- prediabetes or diabetes
- elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
- oral contraceptive use
- contraindication to heparin
- known atherosclerotic cardiovascular disease
- unwilling to abstain from alcohol
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06894004
Start Date
February 24 2025
End Date
November 30 2030
Last Update
March 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110