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Human Requirements for the Nutrient Choline

This study is currently recruiting patients.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this research study is to determine how much choline healthy people need to have in their diets. Choline is a normal part of many foods. It is used in the body to make membranes (the wrappers around cells) and to make a nerve chemical called acetylcholine. Several species of animals need to eat choline; otherwise their livers do not work properly. It is not known whether this is so in humans because they may be able to meet their daily choline requirements by making choline in the liver. This study will test whether humans can make sufficient choline or not when they have less than the usual amount in their diet. This study will also examine whether a diet low in another vitamin, folate, will affect how much choline humans require.

Condition Treatment or Intervention
Healthy
 Procedure: Induction of choline deficiency

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further Study Details: 

Expected Total Enrollment:  80

Study start: September 2000

The objective of this study is to determine the required daily amount (RDA) of choline, a nutrient deemed essential for humans, in adult men and women. At this time the Institute of Medicine has suggested an adequate intake, but has not determined the minimum intake of choline. Choline is used to form membranes (phosphatidlycholine), to form a neurotransmitter (acetylcholine), and as a methyl group donor in biochemical reactions. This report noted that choline is important for normal function, and that it is likely that humans require dietary choline. However, they noted that evidence in humans is insufficient to make accurate estimations of this requirement, and that " …research that could provide such human data is assigned the highest priority." The aim of this study is to determine the dietary choline requirement of adult men and women (pre- and postmenopausal).

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria


Location and Contact Information


North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Leslie M Fischer, PhD, MPH, RD  919-408-3320  Ext. 31    LFischer@email.unc.edu 
Renee Blanchard  919 408-3320  Ext. 21    rblancha@email.unc.edu 
Steven H Zeisel, MD, PhD,  Principal Investigator

More Information

Study ID Numbers:  HRNUT
Record last reviewed:  July 2004
Record first received:  July 28, 2003
ClinicalTrials.gov Identifier:  NCT00065546
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
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