Recruiting

Genetic Variations in LDL Hyper-responders on Ketogenic Diet

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2025
See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactSaad Omar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2025

Actual date on which the first participant was enrolled.

This study is exploring why some individuals on a ketogenic diet, which is high in fats and low in carbohydrates, experience a significant increase in their LDL cholesterol levels. These individuals, known as "hyper-responders," might have specific genetic variations that affect how their bodies absorb cholesterol. The research focuses on identifying these genetic differences, which could help in understanding how diet and genetics interact, potentially leading to better dietary recommendations and treatments for managing cholesterol levels. Participants in the study will not take any medication or undergo treatments. Instead, the study observes their genetic makeup by analyzing specific genes related to cholesterol absorption, such as ABCG5, ABCG8, and others. Researchers will look for mutations in these genes to determine if they are linked to the increased LDL cholesterol levels seen in hyper-responders. The study's main goal is to count how many participants have these genetic mutations, providing insights into the genetic factors that might influence cholesterol levels on a ketogenic diet.

Official TitleGenetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet
NCT07137286
Principal SponsorMayo Clinic
Study ContactSaad Omar
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
Recruiting
One Study Center