Genetic Variations in LDL Hyper-responders on Ketogenic Diet
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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