Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Recruiting now · Not applicable

Conditions studied: Hypercholesterolemia and Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT06894004

Run by

Washington University School of Medicine

People needed

100

Starts

2025-02-24

Expected to finish

2030-11-30

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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

• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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