Dose of Labeled Cholesterol for Kinetics: A Pilot Study

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

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Key information

Conditions

Lipid Metabolism

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stable isotope of cholesterol

Other

Primary outcomes

Incorporation of orally administered 13C3 cholesterol into plasma cholesterol

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 19, 2014
Registry last updated: Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed