LDL Hyper-responsivenessNCT07137286
A Study of Genetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet
An observational study of LDL Hyper-responsiveness, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LDL Hyper-responsiveness
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female participants 18 years and older
Who may be able to join
- 18 years of age or older
- LDL-C >170 mg/dL in response to starting a ketogenic diet
Who cannot join
- Patients who do not consent to blood draw for genetic testing
- Those with LDL-C <170 mg/dL on a ketogenic diet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Saad Omar, 507-538-5162, omar.saad@mayo.edu
Stephen Kopecky, M.D.
About this study
Official title: 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.
- Conditions
- LDL Hyper-responsiveness
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients to have a genetic mutation
Genetic Mutation will be defined as a mutation in ABCG5, ABCG8, APOB, APOE, CETP, CYP27A1, LDLR, LDLRAP1, LIPA, LPL, LRP6, and PCSK9 genes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start11 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LDL Hyper-responsivenessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen L. Kopecky, Mayo Clinic
- Investigators
- Stephen Kopecky, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137286
- Sponsor's protocol ID
- 25-002523
- Status last verified
- Nov 2025
- First submitted
- 15 Aug 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet
- ClinicalTrials.gov ID
- NCT07137286
- Acronym / sponsor ID
- 25-002523
- Conditions
- LDL Hyper-responsiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female participants 18 years and older
Key inclusion criteria (2 listed)
- 18 years of age or older
- LDL-C >170 mg/dL in response to starting a ketogenic diet
Key exclusion criteria (2 listed)
- Patients who do not consent to blood draw for genetic testing
- Those with LDL-C <170 mg/dL on a ketogenic diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Kopecky, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LDL Hyper-responsiveness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad Omar (507-538-5162, omar.saad@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients to have a genetic mutation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.