Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Conditions

• Hypercholesterolemia and Hyperlipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 39 Years

Healthy Volunteers

Accepted

Interventions

• Ketogenic Diet — BEHAVIORAL
  Participants will consume an isocaloric ketogenic diet for 4 weeks with all food provided as packed-out meals.
• Control Diet — BEHAVIORAL
  Participants will consume an isocaloric control diet for 4 weeks with all food provided as packed-out meals.

Study Details

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.

Key Dates

Start date

Feb 24, 2025

Status verified

Mar 2026

Primary completion

Nov 30, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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.

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

• Frannie Wilkinson, M.A.
  (314) 362-0590
  [email protected]
• Max C Petersen, M.D., Ph.D.
  314-362-8352
  [email protected]

Locations (1)

Find similar trials in St Louis, MO