Atlas of Human Milk Nutrients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 13
- 主要终点
- Characterization of human milk components
研究概览
简要总结
The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:
- To assess whether there is a correlation between human milk composition and mothers' diet
- To assess whether there is a correlation between human milk composition and maternal clinical parameters
- To assess whether there is a correlation between human milk composition and mother and infant clinical parameters
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 40 years of age included at time of enrolment
- •BMI before pregnancy between 19 and 29 included
- •Having signed the Informed Consent Form
- •Having decided to exclusively breast-feed until infant is 4 months old
排除标准
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- •Presenting any disease or medical condition which might prevent breast-feeding or collection the human milk samples or for which breast-feeding is not indicated
- •Presenting diseases/medical conditions such as diabetes, heart problems, abnormal conditions of pregnancy (ex. hypertension)
- •Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
- •Assuming any medication indicated for the treatment of any metabolic or cardiovascular disease
- •Cannot be expected to comply with the study procedures
结局指标
主要结局
Characterization of human milk components
时间窗: Between 0 and 4 months after delivery
Nutrients in human breast milk samples will be characterized and quantified by analysing with modern analytical techniques (NMR, HPLC-MS and GC-MS) the human milk samples collected at each study visits (3d, 14 days, 1m, 2m, 3m and 4 months after delivery, 1 week after delivery, ). The parameters which will be assessed in human milk samples are : Total Energy Value, Total Macronutrients (lipids, proteins, carbohydrates, solids), Lipids' characterization, Peptide profiling, Oligosaccharides profiling, and Micro-RNA profiling. It will be done in 240 completed mothers.
次要结局
- Human milk composition versus mothers' diet data(between 3 months before delivery and 4 months after delivery)
- Human milk composition versus maternal clinical parameters(Between 0 and 4 months after delivery)
- Human milk composition versus mother and infant clinical parameters(Between 0 and 4 months after delivery)