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Completed

NCT Number: NCT01127022

Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

About this study

Choline is a micronutrient used for the structural integrity of cell membranes, lipid transport/metabolism, methylation reactions and cholinergic neurotransmission. Prenatal and early postnatal choline exposure plays a critical role in brain development and cognition based on animal data. Although it is recognized that choline use is particularly high during pregnancy and lactation, the level of choline intake needed to optimize maternal and fetal health outcomes is unknown. The primary objective of this study was to investigate the metabolic and genomic effects of two doses of choline intake, 450 mg/d (the adequate intake level for pregnant women) and 900 mg/d in pregnant, lactating, and nonpregnant control women. A secondary objective was to examine the effect of extra maternal choline intake on the child's cognitive performance (i.e, learning, memory and attention). To accomplish these objectives, pregnant women (wk 27 gestation), nonpregnant control women, and lactating women consumed controlled choline intakes of 480 or 930 mg/d for 10 to 12 weeks. The basal diet provided 380 mg/d; supplemental choline chloride, 100 or 550 mg/d, was used to achieve the target intake levels. During the last half of the study, a small portion (~ 20%) of the total choline intake was derived from deuterium labeled choline, a stable isotope. Blood, urine and/or breast milk were collected at baseline and at select timepoints throughout the study duration. For pregnant women, a maternal blood sample was obtained at the time of delivery along with a cord blood sample and the placental tissue. Genomic and metabolomic profiling were performed on the collected biological samples along with specific measurements of choline status. Non-invasive tests assessing cognitive function were performed on the children of the pregnant and lactating study participants. This controlled feeding study has also been extended to investigate dose-response relationships for other micronutrients including folate, vitamin B12, vitamin D, and biotin.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant
  • Healthy
  • Non-smoker

Exclusion criteria

  • Liver or kidney problems
  • Alcohol or illegal drug misuse/abuse

Treatment and study plan

choline chloride

Dietary Supplement

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.

Primary outcomes

  1. Maternal biomarkers of choline status

    Time frame: 10-12 Weeks

Secondary outcomes

  1. Genomic expression as function of maternal choline intake

    Time frame: 10-12 Weeks

  2. Cognitive performance in children of study participants

    Time frame: 12 months

  3. Metabolomic profiling as a function of maternal choline intake

    Time frame: 10-12 Weeks

  4. Biomarkers for additional micronutrients

    Time frame: 10-12 Weeks

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • American Egg Board
  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff
  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
May 20, 2010
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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