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Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Who can join

Ages 18 to 39 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

1. age ≥ 18 and \< 40 years
2. BMI ≥ 18.5 and \< 25.0 kg/m2
3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
5. HbA1c ≤ 5.6%.

Exclusion Criteria:

1. personal or family history of familial hypercholesterolemia
2. current use of lipid-lowering drugs
3. currently on a ketogenic diet and unwilling to change diet
4. current tobacco use
5. hypertension
6. prediabetes or diabetes
7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
8. oral contraceptive use
9. contraindication to heparin
10. known atherosclerotic cardiovascular disease
11. unwilling to abstain from alcohol

About the study

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.

What is being tested

• Ketogenic Diet (behavioral)
• Control Diet (behavioral)

Sponsor: Washington University School of Medicine · Participants: 100 · Started: Feb 24, 2025

Contact the study team

• Frannie Wilkinson, M.A. · Phone: (314) 362-0590
• Max C Petersen, M.D., Ph.D. · Phone: 314-362-8352

Official record on ClinicalTrials.gov — NCT06894004

Locations in the U.S.

Conditions

• Cholesterol
• Hyperlipidemias

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.