Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation
1 other identifier
interventional
82
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started Jan 2009
Typical duration for not_applicable pregnancy
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
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 18, 2013
September 1, 2013
1.9 years
May 17, 2010
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maternal biomarkers of choline status
10-12 Weeks
Secondary Outcomes (4)
Genomic expression as function of maternal choline intake
10-12 Weeks
Cognitive performance in children of study participants
12 months
Metabolomic profiling as a function of maternal choline intake
10-12 Weeks
Biomarkers for additional micronutrients
10-12 Weeks
Study Arms (2)
480 mg/d choline intake
ACTIVE COMPARATOR480 mg/d choline derived from the diet \[380 mg choline/d\] plus supplemental choline chloride \[100 mg choline/d\]
930 mg/d choline intake
EXPERIMENTAL930 mg/d choline derived from the diet \[380 mg choline/d\] plus supplemental choline chloride \[550 mg choline/d\]
Interventions
Women will consume a diet providing 380 mg/d total choline plus 100 mg/d supplemental choline \[from choline chloride\] for a total choline intake of 480 mg/d. The choline chloride will be administered in cran-grape juice.
Eligibility Criteria
You may qualify if:
- Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant
- Healthy
- Non-smoker
You may not qualify if:
- Liver or kidney problems
- Alcohol or illegal drug misuse/abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cornell Universitylead
- American Egg Boardcollaborator
- National Cattlemen's Beef Association, a contractor to the Beef Checkoffcollaborator
- USDA Beltsville Human Nutrition Research Centercollaborator
Study Sites (1)
Human Metabolic Research Unit, Cornell University
Ithaca, New York, 14853, United States
Related Publications (13)
Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Stabler SP, Allen RH, Caudill MA. Maternal choline intake modulates maternal and fetal biomarkers of choline metabolism in humans. Am J Clin Nutr. 2012 May;95(5):1060-71. doi: 10.3945/ajcn.111.022772. Epub 2012 Mar 14.
PMID: 22418088RESULTJiang X, Bar HY, Yan J, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen FM, Wells MT, Caudill MA. Pregnancy induces transcriptional activation of the peripheral innate immune system and increases oxidative DNA damage among healthy third trimester pregnant women. PLoS One. 2012;7(11):e46736. doi: 10.1371/journal.pone.0046736. Epub 2012 Nov 2.
PMID: 23133592RESULTJiang X, Yan J, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Caudill MA. Maternal choline intake alters the epigenetic state of fetal cortisol-regulating genes in humans. FASEB J. 2012 Aug;26(8):3563-74. doi: 10.1096/fj.12-207894. Epub 2012 May 1.
PMID: 22549509RESULTWest AA, Yan J, Perry CA, Jiang X, Malysheva OV, Caudill MA. Folate-status response to a controlled folate intake in nonpregnant, pregnant, and lactating women. Am J Clin Nutr. 2012 Oct;96(4):789-800. doi: 10.3945/ajcn.112.037523. Epub 2012 Aug 29.
PMID: 22932279RESULTJiang X, Bar HY, Yan J, Jones S, Brannon PM, West AA, Perry CA, Ganti A, Pressman E, Devapatla S, Vermeylen F, Wells MT, Caudill MA. A higher maternal choline intake among third-trimester pregnant women lowers placental and circulating concentrations of the antiangiogenic factor fms-like tyrosine kinase-1 (sFLT1). FASEB J. 2013 Mar;27(3):1245-53. doi: 10.1096/fj.12-221648. Epub 2012 Nov 29.
PMID: 23195033RESULTWest AA, Yan J, Jiang X, Perry CA, Innis SM, Caudill MA. Choline intake influences phosphatidylcholine DHA enrichment in nonpregnant women but not in pregnant women in the third trimester. Am J Clin Nutr. 2013 Apr;97(4):718-27. doi: 10.3945/ajcn.112.050211. Epub 2013 Feb 27.
PMID: 23446897RESULTBahnfleth CL, Strupp BJ, Caudill MA, Canfield RL. Prenatal choline supplementation improves child sustained attention: A 7-year follow-up of a randomized controlled feeding trial. FASEB J. 2022 Jan;36(1):e22054. doi: 10.1096/fj.202101217R.
PMID: 34962672DERIVEDKlatt KC, McDougall MQ, Malysheva OV, Brenna JT, Roberson MS, Caudill MA. Reproductive state and choline intake influence enrichment of plasma lysophosphatidylcholine-DHA: a post hoc analysis of a controlled feeding trial. Br J Nutr. 2019 Dec 14;122(11):1221-1229. doi: 10.1017/S0007114519002009.
PMID: 31782377DERIVEDPark H, Brannon PM, West AA, Yan J, Jiang X, Perry CA, Malysheva OV, Mehta S, Caudill MA. Vitamin D Metabolism Varies among Women in Different Reproductive States Consuming the Same Intakes of Vitamin D and Related Nutrients. J Nutr. 2016 Aug;146(8):1537-45. doi: 10.3945/jn.116.229971. Epub 2016 Jun 22.
PMID: 27335139DERIVEDDavenport C, Yan J, Taesuwan S, Shields K, West AA, Jiang X, Perry CA, Malysheva OV, Stabler SP, Allen RH, Caudill MA. Choline intakes exceeding recommendations during human lactation improve breast milk choline content by increasing PEMT pathway metabolites. J Nutr Biochem. 2015 Sep;26(9):903-11. doi: 10.1016/j.jnutbio.2015.03.004. Epub 2015 Apr 15.
PMID: 26025328DERIVEDBae S, West AA, Yan J, Jiang X, Perry CA, Malysheva O, Stabler SP, Allen RH, Caudill MA. Vitamin B-12 Status Differs among Pregnant, Lactating, and Control Women with Equivalent Nutrient Intakes. J Nutr. 2015 Jul;145(7):1507-14. doi: 10.3945/jn.115.210757. Epub 2015 May 20.
PMID: 25995278DERIVEDPerry CA, West AA, Gayle A, Lucas LK, Yan J, Jiang X, Malysheva O, Caudill MA. Pregnancy and lactation alter biomarkers of biotin metabolism in women consuming a controlled diet. J Nutr. 2014 Dec;144(12):1977-84. doi: 10.3945/jn.114.194472. Epub 2014 Aug 13.
PMID: 25122647DERIVEDYan J, Jiang X, West AA, Perry CA, Malysheva OV, Brenna JT, Stabler SP, Allen RH, Gregory JF 3rd, Caudill MA. Pregnancy alters choline dynamics: results of a randomized trial using stable isotope methodology in pregnant and nonpregnant women. Am J Clin Nutr. 2013 Dec;98(6):1459-67. doi: 10.3945/ajcn.113.066092. Epub 2013 Oct 16.
PMID: 24132975DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie A Caudill, PhD, RD
Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 20, 2010
Study Start
January 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
September 18, 2013
Record last verified: 2013-09