Dose of Labeled Cholesterol for Kinetics: A Pilot Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02065817

Enrollment

Registered

2014-02-19

Start date

2014-02-28

Completion date

2015-12-31

Last updated

2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipid Metabolism

Keywords

Lipid, Apolipoproteins, Cardiovascular disease risks

Brief summary

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

Interventions

OTHERstable isotope of cholesterol

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026