Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
Recruiting · NCT06894004 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Control DietKetogenic Diet
What this trial 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. 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.
Who can take part
Age range
18 Years to 39 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States