RecruitingNot ApplicableNCT06894004

Mechanism of Ketogenic Diet-Induced Hypercholesterolemia


Sponsor

Washington University School of Medicine

Enrollment

100 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 39 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

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Interventions

BEHAVIORALKetogenic Diet

Participants will consume an isocaloric ketogenic diet for 4 weeks with all food provided as packed-out meals.

BEHAVIORALControl 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

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NCT06894004


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