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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Lactation

Keywords

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Pregnancy Lactation Choline Cognition Biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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480 mg/d choline intake

480 mg/d choline derived from the diet \[380 mg choline/d\] plus supplemental choline chloride \[100 mg choline/d\]

Group Type ACTIVE_COMPARATOR

choline chloride

Intervention Type 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.

930 mg/d choline intake

930 mg/d choline derived from the diet \[380 mg choline/d\] plus supplemental choline chloride \[550 mg choline/d\]

Group Type EXPERIMENTAL

Choline Chloride

Intervention Type DIETARY_SUPPLEMENT

Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline \[from choline chloride\] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.

Interventions

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choline chloride

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.

Intervention Type DIETARY_SUPPLEMENT

Choline Chloride

Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline \[from choline chloride\] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie A Caudill, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

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Human Metabolic Research Unit, Cornell University

Ithaca, New York, United States

Site Status

Countries

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United States

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OSP No: 59370, 57100, 58222

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

480 mg/d choline intake

choline chloride

930 mg/d choline intake

Choline Chloride

Interventions

choline chloride

Choline Chloride

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

American Egg Board

National Cattlemen's Beef Association

USDA Beltsville Human Nutrition Research Center

Cornell University

Responsible Party

Principal Investigators

Marie A Caudill, PhD, RD

Locations

Human Metabolic Research Unit, Cornell University

Countries

References

Jiang 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.

West 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.

West 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.

Bahnfleth 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.

Klatt 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.

Bae 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.

Perry 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.

Other Identifiers

OSP No: 59370, 57100, 58222