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临床试验/NCT01127022
NCT01127022已完成不适用

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

Cornell University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Maternal biomarkers of choline status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

930 mg/d choline intake

Experimental

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

干预措施: Choline Chloride (Dietary Supplement)

480 mg/d choline intake

Active Comparator

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

干预措施: choline chloride (Dietary Supplement)

结局指标

主要结局

Maternal biomarkers of choline status

时间窗: 10-12 Weeks

次要结局

  • Biomarkers for additional micronutrients(10-12 Weeks)
  • Cognitive performance in children of study participants(12 months)
  • Metabolomic profiling as a function of maternal choline intake(10-12 Weeks)
  • Genomic expression as function of maternal choline intake(10-12 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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