Genetic causes of large LDL increases after starting a ketogenic diet
Official title: Genetic Influence on LDL Hyper-responsiveness in Patients Following a Ketogenic Diet
Run by Mayo Clinic · NCT07137286 · Data updated 2026-11-12
This will test whether people who start a ketogenic diet and then have very large increases in LDL cholesterol carry genetic differences in genes that affect cholesterol absorption.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07137286 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18+) who began a ketogenic diet and have LDL-C above 170 mg/dL on that diet and who agree to a blood draw for genetic testing are the intended participants.
✕Probably not a fit
People whose LDL-C remains below 170 mg/dL on a ketogenic diet or who decline genetic testing are unlikely to receive direct benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study enrolls adults who developed LDL-C >170 mg/dL after starting a ketogenic diet and consent to a blood draw. Participants provide a blood sample for genetic testing and investigators will sequence or genotype genes involved in intestinal cholesterol absorption (for example NPC1L1, ABCG5, ABCG8) to look for variants linked to the hyper-responder pattern. No treatment is given and dietary changes are not required by the protocol. Researchers will compare identified variants with known population frequencies to determine whether specific genetic differences are overrepresented among hyper-responders.
Why it matters
Potential benefit: If successful, the results could help predict who is likely to have large LDL rises on a ketogenic diet and support more personalized dietary guidance.
How similar studies have gone: Genetic studies have previously identified variants that affect cholesterol handling, but applying genetics specifically to explain ketogenic-diet LDL hyper-responsiveness is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Stephen Kopecky, M.D. — Mayo Clinic
- Study coordinator: Saad Omar
- Email: omar.saad@mayo.edu
- Phone: 507-538-5162
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.