A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)

A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01101763

Enrollment

Registered

2010-04-12

Start date

2008-08-31

Completion date

2008-12-31

Last updated

2015-04-22

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

Conditions

Dyslipidemia

Brief summary

This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of \[13C3,4\]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and whether the mean difference in repeat Ra measurements is below is a prespecified level.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is male 18 to 45 years of age at screening * Subject has a stable weight (± 2 kg) for more then 6 weeks prior to screening

Exclusion criteria

* Subject has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption * Subject has an active or recent (\<2 weeks) gastrointestinal condition (gastroenteritis, diarrhea, chronic constipation, irritable bowl syndrome, etc.) affecting bowel movements * Subject has a known allergy to beans, peas, eggs or egg-derived products and/or soy or soy-derived products * Subject has a history of plant sterol storage disease (sitosterolemia, cerebrotendinotic xanthomatosis) or a history of intolerance to plant sterols and/or plant sterol containing products * Subject has a history of hepatic or gall bladder disease (including gallstones, cholecystectomy, etc.) * Subject is currently taking psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies that are known to affect serum lipids * Subject has taken lipid-lowering agents within 6 weeks prior to screening * Subject has previously been administered an intravenous infusion of \[13C3,4\]-cholesterol

Design outcomes

Primary

Measure	Time frame
%APE (atom percent enrichment) for all study subjects in Part I at 18 hours	18 hours
Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool	Baseline and 4 weeks

Outcome results