Actively Recruiting
Mechanism of Ketogenic Diet-Induced Hypercholesterolemia and Lipoprotein Kinetics in Normal-Weight Adults
Led by Washington University School of Medicine · Updated on 2026-03-23
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating why very-low carbohydrate ketogenic diets can cause a significant rise in blood cholesterol levels in some normal-weight adults. This study focuses on identifying individuals who develop high cholesterol when following a ketogenic diet and understanding the underlying mechanism. The goal is to clarify how this diet affects cholesterol-carrying particles, known as lipoproteins, in susceptible people. The study involves a two-stage screening process to find eligible normal-weight adults with low cardiovascular risk and identify "responders" who show increased LDL cholesterol after a 3-week ketogenic diet. Qualified responders will then participate in a randomized crossover trial comparing two 4-week diet interventions: a ketogenic diet and a control diet. Each diet phase is separated by a 4-week washout period, and all food is provided as packed-out meals. Participants are assigned to one of two groups, starting with either the ketogenic or control diet. Participants will undergo detailed assessments including isotope tracer studies to measure production and removal rates of various lipoproteins and cholesterol kinetics immediately after each diet period. Additional evaluations include blood lipoprotein profiles, fat mass, insulin sensitivity, thyroid function, and cholesterol absorption markers. The study aims to understand how ketogenic diets impact cholesterol metabolism, with all procedures conducted under careful monitoring over several months.
CONDITIONS
Brief Title
Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 40 years
- Body mass index (BMI) between 18.5 and less than 25.0 kg/m2
- Baseline LDL cholesterol less than 150 mg/dL (less than 3.9 mmol/L)
- Baseline triglycerides less than 100 mg/dL (less than 1.1 mmol/L)
- HbA1c 5.6% or less
You will not qualify if you...
- Personal or family history of familial hypercholesterolemia
- Current use of lipid-lowering medications
- Currently on a ketogenic diet and unwilling to change
- Current tobacco use
- Hypertension
- Prediabetes or diabetes
- Elevated Lp(a) greater than 6.5% of ApoB-containing lipoproteins at baseline
- Use of oral contraceptives
- Contraindication to heparin
- Known atherosclerotic cardiovascular disease
- Unwillingness to abstain from alcohol
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including a 3-week screening ketogenic diet
Duration - Approximately 12 weeks total
Participants who respond to the screening ketogenic diet will complete two 4-week dietary interventions (ketogenic diet and control diet) in random order, with all food provided as packed-out meals. There is a 4-week washout period between the interventions.
Visits at the start and end of each 4-week diet and during the 4-week washout
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
F
Frannie Wilkinson, M.A.
M
Max C Petersen, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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