Dose of Labeled Cholesterol for Kinetics: A Pilot Study

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02065817
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 21.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lipid Metabolism	Other: stable isotope of cholesterol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Dose of Labeled Cholesterol and Phenylalanine for HDL Kinetics: A Pilot Study
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tracer	Other: stable isotope of cholesterol

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: John M Miles, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ananda Basu, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02065817
• Other Study ID Numbers: 13-004890
• First Posted: Feb 19, 2014
• Last Update Posted: Jan 7, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Ananda Basu, PI, Mayo Clinic: Lipid; Apolipoproteins; Cardiovascular disease risks

Study Results

No Results Posted as of Jan 7, 2016