Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 18, 2025
Trial Information
Current as of June 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a very-low carbohydrate ketogenic diet can lead to high cholesterol levels in some people, especially those who are of normal weight. Researchers want to understand why this happens by enrolling normal-weight adults who might experience an increase in cholesterol while following this diet. They will identify these individuals, called "responders," and measure how their bodies produce and remove certain cholesterol-carrying particles, known as lipoproteins. The goal is to clarify the reasons behind the rise in cholesterol levels for those who are more susceptible.
To participate in this trial, you need to be between 18 and 40 years old, have a healthy body weight (BMI between 18.5 and 25), and have specific cholesterol levels that are not too high at the start. If you are currently on certain medications, have a family history of high cholesterol, or have other health issues like diabetes or high blood pressure, you may not be eligible to join. Participants can expect to follow the ketogenic diet as part of the study and will be closely monitored for changes in their cholesterol levels. This research could help provide important insights into how diets affect cholesterol levels and overall heart health.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. age ≥ 18 and \< 40 years
- • 2. BMI ≥ 18.5 and \< 25.0 kg/m2
- • 3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
- • 4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
- • 5. HbA1c ≤ 5.6%.
- Exclusion Criteria:
- • 1. personal or family history of familial hypercholesterolemia
- • 2. current use of lipid-lowering drugs
- • 3. currently on a ketogenic diet and unwilling to change diet
- • 4. current tobacco use
- • 5. hypertension
- • 6. prediabetes or diabetes
- • 7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
- • 8. oral contraceptive use
- • 9. contraindication to heparin
- • 10. known atherosclerotic cardiovascular disease
- • 11. unwilling to abstain from alcohol
About Washington University School Of Medicine
Washington University School of Medicine is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research, education, and patient care. With a strong emphasis on translating scientific discoveries into practical applications, the institution conducts a diverse array of clinical trials aimed at improving treatment outcomes and enhancing the understanding of various medical conditions. Its collaborative environment fosters partnerships between researchers, clinicians, and community stakeholders, ensuring that the trials not only contribute to scientific knowledge but also address the pressing health needs of diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Louis, Missouri, United States
Patients applied
Trial Officials
Max C Petersen, M.D., Ph.D.
Principal Investigator
Washington University School of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported