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Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

NCT06894004 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Hypercholesterolemia and Hyperlipidemia

Interventions

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Max C Petersen, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2030-11-30
Completion
2030-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894004 on ClinicalTrials.gov