NCT00328211|CompletedDMC
Loading search results
Sponsor study identifier
Secondary identifiers
NIH
interventional
35
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
May 18, 2006
Actual (reported)May 19, 2006
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)The primary outcomes for this study are to better understand the molecular and cellular mechanisms of cholesterol metabolism and absorption.
5 yrs
To assess the role of bile acid pool size changes on cholesterol absorption, synthesis and intralumenal cholesterol solubilization.
To determine whether cholesterol absorption, synthesis and solubilization will be significantly altered by changes in phospholipid content, specifically sphingolipids and phosphatidylcholine in the intestinal lumen.
15 mg/kg/day for 18 days
1000mg/day for 19 days
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Yao L, Heubi JE, Buckley DD, Fierra H, Setchell KD, Granholm NA, Tso P, Hui DY, Woollett LA. Separation of micelles and vesicles within lumenal aspirates from healthy humans: solubilization of cholesterol after a meal. J Lipid Res. 2002 Apr;43(4):654-60.
Woollett LA, Buckley DD, Yao L, Jones PJ, Granholm NA, Tolley EA, Heubi JE. Effect of ursodeoxycholic acid on cholesterol absorption and metabolism in humans. J Lipid Res. 2003 May;44(5):935-42. doi: 10.1194/jlr.M200478-JLR200. Epub 2003 Mar 1.
James E. Heubi, M.D.
Children's Hospital Medical Center, Cincinnati
35 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2006
First Posted
May 19, 2006
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions
To assess intralumenal solubilization and absorption of biliary and dietary cholesterol.
Food provided for 3 days and one time dose of 113mg of C13 Cholesterol.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Woollett LA, Buckley DD, Yao L, Jones PJ, Granholm NA, Tolley EA, Tso P, Heubi JE. Cholic acid supplementation enhances cholesterol absorption in humans. Gastroenterology. 2004 Mar;126(3):724-31. doi: 10.1053/j.gastro.2003.11.058.
Woollett LA, Wang Y, Buckley DD, Yao L, Chin S, Granholm N, Jones PJ, Setchell KD, Tso P, Heubi JE. Micellar solubilisation of cholesterol is essential for absorption in humans. Gut. 2006 Feb;55(2):197-204. doi: 10.1136/gut.2005.069906.
Ramprasath VR, Jones PJ, Buckley DD, Woollett LA, Heubi JE. Effect of dietary sphingomyelin on absorption and fractional synthetic rate of cholesterol and serum lipid profile in humans. Lipids Health Dis. 2013 Aug 19;12:125. doi: 10.1186/1476-511X-12-125.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
September 10, 2020
Record last verified: 2020-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: