Human Requirements for the Nutrient Choline

Completed · Not applicable · Has a placebo group

Conditions studied: Postmenopausal Women

In brief

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.

Key facts

Study ID

NCT00065546

Run by

University of North Carolina, Chapel Hill

People needed

43

Starts

2007-06-01

Expected to finish

2012-01-01

Last updated by the study team

2012-01-06

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy
• Non-smoker
• BMI between 18 and 34
• Normal mammogram in last 12 months (post-menopausal women only)

You may not qualify if…

• Hormone or estrogen therapy
• Allergic to soy, eggs, wheat
• History of breast, uterine, or other estrogen-dependent cancer
• Liver or kidney problems
• History of circulation, bleeding, or blood-clotting disorder
• Anemia or evidence of iron overload
• Hyperthyroidism, neurological disorder, or autoimmune disease
• Diabetes controlled by insulin
• Positive serology for HIV or Hepatitis B or C
• Alcohol or illegal drug misuse/abuse
• Pacemaker, aneurysm clip, cardiac heart valve, mechanical devices/implants
• Other metal in body (i.e. injured by a BB, shrapnel, or metallic object)

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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