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临床试验/NCT03842891
NCT03842891已完成不适用

Genetic Variants Modulate Association Between Dietary n-3 LCPUFAs and DHA Proportion in Breast Milk

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2017年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
193
试验地点
1
主要终点
Breast milk fatty acid composition

研究概览

简要总结

DHA is important for the development of brain and retina in newborns. Considering that exclusive breast feeding for at least 4 ~6 months are globally recommended, plus it is well known that nutrient requirement is determined by both genetic and environmental (including diet) factors, this clinical study sought to investigate how the DHA levels in maternal milk is modulated by genetic variants and dietary n-3 LCPUFA intake. To recruit subjects (n=193), the inclusion criteria are Han Chinese women just having delivered full-term baby, 20-40 years old, healthy, and willing to breast feed their baby for at least 2 months. Written informed consent will be obtained from participants. Personal information (or covariates) such as height, weight (before getting pregnancy and delivery, respectively), age, parity, education, smoking, alcohol drinking, gender of baby...etc, and DNA from oral swab will be collected. Breast milk and dietary data will be collected at the end of the 1st and 2nd month of postpartum period. Considering Han Chinese women usually have special postpartum diets and care during puerperium, therefore, collection of breast milk and dietary information will be repeated at the 2nd month. The fatty acid composition in milk will be analyzed by gas chromatography. Using food frequency questionnaire, intake of n-3 LCPUFA from foods + fish oil supplements will be calculated. Subjects will be instructed to give a 3-days food record as well. We foresee results of this study might contribute to public health care as nutritionists/dietitians will be able to target the vulnerable subjects, who are dietary dependent for DHA, for dedications in nutrition consults or customized dietary guidance. Moreover, these information are valuable in making policy regarding dietary recommendation in Taiwan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Han Chinese women
  • Full-term pregnancy(>36weeks)
  • 20-40 years old
  • Breast feed their baby for at least 2 months

排除标准

  • Death before and after childbirth
  • Child with congenital disease

结局指标

主要结局

Breast milk fatty acid composition

时间窗: 2 month

Breast milk will be collected at the end of the 1st and 2nd month of postpartum period.The fatty acid composition in milk will be analyzed by gas chromatography.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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