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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by (Responsible Party): | Steven Zeisel, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00065546 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Postmenopausal Women |
Other: Estrogen plus choline depletion diet Other: Placebo plus choline depletion diet Other: Pre-menopausal women with SNPs given a low choline diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | Human Requirements for the Nutrient Choline |
| Enrollment: | 43 |
| Study Start Date: | June 2007 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Post-menopausal women randomized to receive estrogen replacement therapy.
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Other: Estrogen plus choline depletion diet
Post-menopausal subjects receive estrogen and are then challenged with a low choline diet to determine if estrogen protects them from induction of choline deficiency.
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Placebo Comparator: 2
Post-menopausal women randomized to receive a placebo.
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Other: Placebo plus choline depletion diet
Post-menopausal women are randomized to receive a placebo and are then subjected to a low choline diet to determine if clinical signs of choline deficiency can be induced.
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Experimental: 3
Pre-menopausal women with specific genetic variants.
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Other: Pre-menopausal women with SNPs given a low choline diet
Pre-menopausal women with specific genetic polymorphisms in genes related to choline metabolism are placed on a choline depletion diet to determine if the SNPs increase or decrease the risk of diet-induced choline deficiency.
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Choline is an essential nutrient essential used for the structural integrity and signaling functions of cell membranes, cholinergic neurotransmission, and lipid transport/metabolism. 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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Steven H Zeisel, MD, PhD | University of North Carolina, Chapel Hill |
| Study Director: | Leslie M Fischer, PhD, MPH, RD | University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | Steven Zeisel, Professor of Nutrition and Pediatrics, Director, UNC Nutrition Research Institute, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00065546 History of Changes |
| Other Study ID Numbers: | DK55865, R01DK055865 |
| Study First Received: | July 28, 2003 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
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Choline Estrogens Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents |
Therapeutic Uses Lipid Regulating Agents Nootropic Agents Central Nervous System Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
