RECRUITING

Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.

Official Title

Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Quick Facts

Study Start:2025-02-24
Study Completion:2030-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06894004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age ≥ 18 and \< 40 years
  2. 2. BMI ≥ 18.5 and \< 25.0 kg/m2
  3. 3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
  4. 4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
  5. 5. HbA1c ≤ 5.6%.
  1. 1. personal or family history of familial hypercholesterolemia
  2. 2. current use of lipid-lowering drugs
  3. 3. currently on a ketogenic diet and unwilling to change diet
  4. 4. current tobacco use
  5. 5. hypertension
  6. 6. prediabetes or diabetes
  7. 7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
  8. 8. oral contraceptive use
  9. 9. contraindication to heparin
  10. 10. known atherosclerotic cardiovascular disease
  11. 11. unwilling to abstain from alcohol

Contacts and Locations

Study Contact

Nikki Plassmeyer, M.A., R.D.N., L.D.
CONTACT
(314) 362-0590
nikkip@wustl.edu
Max C Petersen, M.D., Ph.D.
CONTACT
314-362-8450
max.p@wustl.edu

Principal Investigator

Max C Petersen, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Max C Petersen, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2030-11-30

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2030-11-30

Terms related to this study

Keywords Provided by Researchers

  • LDL-cholesterol
  • cholesterol
  • ketogenic diet
  • lipoprotein kinetics

Additional Relevant MeSH Terms

  • Hypercholesterolemia and Hyperlipidemia