Human Requirements for the Nutrient Choline
2 other identifiers
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2003
CompletedFirst Posted
Study publicly available on registry
July 31, 2003
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 6, 2012
January 1, 2012
2.3 years
July 28, 2003
January 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of liver or muscle dysfunction (based on elevations in CPK, AST, ALT), or increased liver fat (measured by liver MRI)
Labs measured every 3-4 days throughout 62-day trial. Liver MRI performed on study days 1, 10, 31, 52, 62.
Study Arms (3)
1
ACTIVE COMPARATORPost-menopausal women randomized to receive estrogen replacement therapy.
2
PLACEBO COMPARATORPost-menopausal women randomized to receive a placebo.
3
EXPERIMENTALPre-menopausal women with specific genetic variants.
Interventions
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.
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.
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.
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Related Publications (3)
da Costa KA, Corbin KD, Niculescu MD, Galanko JA, Zeisel SH. Identification of new genetic polymorphisms that alter the dietary requirement for choline and vary in their distribution across ethnic and racial groups. FASEB J. 2014 Jul;28(7):2970-8. doi: 10.1096/fj.14-249557. Epub 2014 Mar 26.
PMID: 24671709DERIVEDda Costa KA, Sanders LM, Fischer LM, Zeisel SH. Docosahexaenoic acid in plasma phosphatidylcholine may be a potential marker for in vivo phosphatidylethanolamine N-methyltransferase activity in humans. Am J Clin Nutr. 2011 May;93(5):968-74. doi: 10.3945/ajcn.110.011064. Epub 2011 Mar 16.
PMID: 21411618DERIVEDFischer LM, da Costa KA, Kwock L, Galanko J, Zeisel SH. Dietary choline requirements of women: effects of estrogen and genetic variation. Am J Clin Nutr. 2010 Nov;92(5):1113-9. doi: 10.3945/ajcn.2010.30064. Epub 2010 Sep 22.
PMID: 20861172DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nutrition and Pediatrics, Director, UNC Nutrition Research Institute
Study Record Dates
First Submitted
July 28, 2003
First Posted
July 31, 2003
Study Start
June 1, 2007
Primary Completion
September 1, 2009
Study Completion
January 1, 2012
Last Updated
January 6, 2012
Record last verified: 2012-01