Recruiting

Ketogenic Diet

Sponsor:

Mayo Clinic

Code:

NCT07137286

Conditions

LDL Hyper-responsiveness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to identify whether individuals following a ketogenic diet who experience extreme LDL-C elevation, termed "hyper-responders", have identifiable genetic variations in genes involved in cholesterol absorption.

Conditions

LDL Hyper-responsiveness

Study ID

NCT07137286

Start date

Sep 11, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older
  • LDL-C >170 mg/dL in response to starting a ketogenic diet

Exclusion Criteria:

  • Patients who do not consent to blood draw for genetic testing
  • Those with LDL-C <170 mg/dL on a ketogenic diet

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of Patients to have a genetic mutation [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Saad Omar

507-538-5162omar.saad@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Saad Omar

507-538-5162omar.saad@mayo.edu

Principal Investigator:

Stephen Kopecky, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-20.