NCT06894004 · Washington University School of Medicine
Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
What this study is about
Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood.
View original scientific description
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-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.
Interventions
BEHAVIORAL
Ketogenic Diet
Participants will consume an isocaloric ketogenic diet for 4 weeks with all food provided as packed-out meals.
BEHAVIORAL
Control Diet
Participants will consume an isocaloric control diet for 4 weeks with all food provided as packed-out meals.
Primary outcome measures
VLDL-ApoB100 production rate
Time frame: Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
Determined by using plasma and VLDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations