The Influence of Various Maternal, Infant and Environmental Factors on Human Milk Composition Among Lithuanian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Quantification of total protein concentration in human milk
研究概览
简要总结
This study aims for characterization of different maternal, infant and environmental factors (e.g. maternal age, pregnancy duration, lactation period, baby gender, circadian rhythm, Holder pasteurisation, etc.) that influence human milk composition.
详细描述
The study consists of three parts. In the first part the investigators aim to evaluate human milk macronutrient composition depending on the time after delivery and pregnancy duration.
In the second part the investigators aim to evaluate the circadian variation of human milk macronutrient and energy content depending on pregnancy duration.
In the third part the investigators aim to evaluate the influence of Holder pasteurisation on human milk macronutrient, metabolome and bioactive protein (lysozyme and lactoferrin) content.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •having obtained informed consent; after a single-birth pregnancy; women who were not on a special diet; lactating mothers who could not breastfeed their newborns due to the baby's medical condition (either prematurity or disease) but who expressed milk.
排除标准
- •breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.
结局指标
主要结局
Quantification of total protein concentration in human milk
时间窗: from the 2nd week, up to 2 months after delivery
Mid-infrared spectrophotometry
次要结局
- Quantification of lysozyme in human milk(14-16 days after delivery)
- Quantification of lactoferrin in human milk(14-16 days after delivery)
- Quantification of total lipids and carbohydrate in human milk(from the 2nd week, up to 2 months after delivery)
- Human milk metabolome analysis(15-17 days after delivery)