Human Requirements for the Nutrient Choline

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.

Conditions

• Postmenopausal Women

Interventions

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.

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.

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Steven H Zeisel, MD, PhD · University of North Carolina, Chapel Hill

• Leslie M Fischer, PhD, MPH, RD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2009-09-30

Completion

2012-01-31

Countries

• United States

Study Locations