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NCT Number: NCT07137286

A Study of Genetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Saad Omar

CONTACT

[email protected]

507-538-5162

Stephen Kopecky, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Patients to have a genetic mutation

    Time frame: Baseline

    Genetic Mutation will be defined as a mutation in ABCG5, ABCG8, APOB, APOE, CETP, CYP27A1, LDLR, LDLRAP1, LIPA, LPL, LRP6, and PCSK9 genes

Study contacts

Contact information is provided by the study sponsor or research team.

Saad Omar

CONTACT

[email protected]

507-538-5162

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Genetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.