Dose of Labeled Cholesterol for Kinetics: A Pilot Study

Not Applicable

Completed

• Conditions: Lipid Metabolism

• Registration Number: NCT02065817
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-19
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incorporation of orally administered 13C3 cholesterol into plasma cholesterol	72 hours	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States