Dose of Labeled Cholesterol for Kinetics: A Pilot Study

Lipid Metabolism Clinical Trial

Official title:

Dose of Labeled Cholesterol and Phenylalanine for HDL Kinetics: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065817
• Other study ID #: 13-004890
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: January 5, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy men and women ages 18 - 50

Exclusion Criteria:

• Cardiovascular disease

• Metabolic disease

• Hematologic disorder

• Liver or kidney disease

• phenylketonuria

• Currently taking lipid lowering medications or any other drugs that could affect lipid metabolism

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lipid Metabolism

Intervention

Other:
• stable isotope of cholesterol

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incorporation of orally administered 13C3 cholesterol into plasma cholesterol	13C3 cholesterol, which is labeled with a stable isotope, will be administered orally. Blood samples will be taken every 4-6 hours for 72 hours for the measurement of stable isotopic enrichment in cholesterol using gas chromatography-mass spectrometry. The study has a dual purpose: to determine the optimum oral dose of isotope, and to determine the time of peak enrichment in plasma cholesterol.	72 hours	No