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Search / Trial NCT06894004

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

Ldl Cholesterol Cholesterol Ketogenic Diet Lipoprotein Kinetics

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.

Locations

Saint Louis, Missouri, United States

Patients applied

0 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