Recruiting

Ketogenic Diet

Sponsor:

Washington University School of Medicine

Code:

NCT06894004

Conditions

Hypercholesterolemia and Hyperlipidemia

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

Ketogenic Diet

Control Diet

Study Details

Brief 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

Study ID

NCT06894004

Start date

Feb 24, 2025

Status verified date

Mar, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: A

Arm A will complete the Ketogenic Diet intervention first, followed by the Control Diet intervention after a 4-week washout period.

experimental: B

Arm B will complete the Control Diet intervention first, followed by the Ketogenic Diet intervention after a 4-week washout period.

Interventions

Ketogenic Diet

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

Control Diet

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

Primary outcome measure

  • VLDL-ApoB100 production rate [ Time Frame: Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period. ]

Central Contacts and Locations

Central contacts

Frannie Wilkinson, M.A.

(314) 362-0590francesw@wustl.edu

Max C Petersen, M.D., Ph.D.

314-362-8352max.p@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Nikki Plassmeyer, M.A., R.D.N., L.D.

(314) 362-0590nikkip@wustl.edu

Max C Petersen, M.D., Ph.D.

314-362-8450max.p@wustl.edu

Principal Investigator:

Max C Petersen, M.D., Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • LDL-cholesterol
  • cholesterol
  • ketogenic diet
  • lipoprotein kinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-23.