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RECRUITINGINTERVENTIONAL

Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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%. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Washington University School of Medicine
St Louis, Missouri, United States