Viewing Study NCT00065546



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Study NCT ID: NCT00065546
Status: COMPLETED
Last Update Posted: 2012-01-06
First Post: 2003-07-28

Brief Title: Human Requirements for the Nutrient Choline
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: Human Requirements for the Nutrient Choline
Status: COMPLETED
Status Verified Date: 2012-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to increase our understanding of how much choline humans need to get from their diet Choline is an essential nutrient found in many foods including eggs and milk In addition to dietary sources choline can be made in the liver Choline is important in making membranes or wrappers for all the cells in the body and for making chemicals that allow nerve cells to work properly In a previous study we found that the dietary requirement for choline varies greatly from person to person This was caused in part by how much estrogen a person has and their genetic makeup We are conducting this study to explore how estrogen levels and specific differences in genes influence choline requirements so that we can refine the dietary recommendations for this nutrient
Detailed Description: Choline is an essential nutrient essential used for the structural integrity and signaling functions of cell membranes cholinergic neurotransmission and lipid transportmetabolism Choline is obtained from the diet and from endogenous biosynthesis catalyzed by the enzyme phosphatidylethanolamine N-methyltransferase PEMT The major premise for this proposal is that humans require a dietary source of choline and that this requirement has significant individual variation and is modulated by estrogen and common genetic polymorphisms The promoter of the PEMT gene is estrogen responsive and we hypothesize that estrogen status influences the dietary requirement for choline We identified other common single nucleotide polymorphisms SNPs that increase or decrease the likelihood that a human will develop organ dysfunction when fed a low choline diet Experiments are proposed that will refine our understanding of estrogen-mediated induction of the PEMT promoter determine whether postmenopausal women treated with estrogen have a decreased susceptibility to developing organ dysfunction associated with choline deficiency determine the prevalence of SNPs that increase susceptibility to choline deficiency in the population and examine dietary choline requirements in humans with these SNPs

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01DK055865 NIH None httpsreporternihgovquickSearchR01DK055865