CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Bile Acids (Cholic, Ursodeoxycholic, Chenodeoxycholic) +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00328211
NCT00328211N/ACompleted

Intralumenal Effects on Cholesterol Absorption/Synthesis

Children's Hospital Medical Center, Cincinnati·interventional·Posted May 19, 2006·Updated Sep 10, 2020

In Brief

A clinical study evaluating Bile Acids (Cholic, Ursodeoxycholic, Chenodeoxycholic), Sphingomyelin, and 1 other intervention for Healthy. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The overall goal of this study is to better understand how cholesterol is absorbed and utilized in the body(metabolism) and how serum cholesterol affects the development of hardening of the arteries (atherosclerosis). The purpose of aim 1 is to assess the role of the amount of different bile acids in the intestine and how they affect the absorption, synthesis and digestion of cholesterol. The effect that these bile acids have on how fast the gall bladder empties and the release of a hormone in the blood after a meal will also be studied. The purpose of aim 2 is to assess the role of phospholipid (a fat containing the element phosphorus) in the intestine and how it affects the absorption, synthesis and digestion of cholesterol in normal people and in people with a genetic condition (mdr3 deficiency)that affects phospholipid and bile acid metabolism. The purpose of aim 3 is to assess the role of a material that acts like a detergent called Pluronic F-68 which is known to block the absorption of cholesterol. The purpose of aim 4 is to determine if the cholesterol from food and the cholesterol made by the body are digested and absorbed differently.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2006
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 20.1 years ago

Interventions

Bile Acids (Cholic, Ursodeoxycholic, Chenodeoxycholic)dietary

15 mg/kg/day for 18 days

Sphingomyelindietary

1000mg/day for 19 days

C13 Stable isotope of Cholesterolother

Food provided for 3 days and one time dose of 113mg of C13 Cholesterol.