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

Study Overview
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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.

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

Conditions
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Pregnancy, Lactation

Intervention / Treatment
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* Dietary Supplement: choline chloride
* Dietary Supplement: Choline Chloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 480 mg/d choline intake<br>480 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [100 mg choline/d] | Dietary Supplement: choline chloride<br>* 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.<br>|
| Experimental: 930 mg/d choline intake<br>930 mg/d choline derived from the diet [380 mg choline/d] plus supplemental choline chloride [550 mg choline/d] | Dietary Supplement: Choline Chloride<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal biomarkers of choline status |  | 10-12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Lactation, Choline, Cognition, Biomarkers