Functional Deconstruction of Human Milk Oligosaccharides and Lipids
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Human milk glycans
研究概览
简要总结
This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.
详细描述
This study's objectives include: 1) develop a better understanding of the composition and structures of breast milk over the early stages of lactation with specific emphasis on the glycans and lipids; 2) how glycan diversity relates to maternal and infant gut microbiota with an emphasis on bifidobacteria species; 3)how milk composition and structure relate to maternal health and diet.
These samples will be analyzed using comprehensive gas and liquid chromatographic methods, nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS); and next generation sequencing, terminal restriction fragment length polymorphism and quantitative polymerase chain reaction.
There are several cohorts to the main study.
Gestational Diabetes Mellitus Cohort. The aim of this study is to investigate the differences between milk composition, infant and maternal gut microbiota from women with and without gestational diabetes mellitus or type 2 diabetes vs. controls.
Fresh Milk Study. The aim of this study is to elucidate the relationship between the expression of glycan metabolizing genes of mammary epithelial cells and levels of milk glycans.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women 18 years and older who plan to breastfeed for at least 6 months
- •Women who are in good health
- •Women with or without diagnosis of gestational diabetes mellitus, or type 2 diabetes mellitus or impaired glucose tolerance
排除标准
- •Women who do not plan to breastfeed for at least 6 months
- •Women who give birth to pre-term infants
- •Women who smoke, either currently or 1 year before becoming pregnant
- •Women who have chronic medical conditions or communicable diseases
- •Women who take metabolic altering drugs such as corticosteroids or thyroid medication
结局指标
主要结局
Human milk glycans
时间窗: Change from day 2 to day 366
Human milk glycans: human milk oligosaccharides and glycoconjugates to lipids, proteins and peptides will be measured by MS methods.
次要结局
- Peptidome(3rd trimester pregnancy and Day 2-Day 366)
- Maternal plasma lipoprotein size distribution(3rd trimester of pregnancy and Day 60 postpartum)
- Maternal plasma lipids(3rd trimester pregnancy and 2 months postpartum)
- Metabolome by Nuclear Magnetic Spectroscopy (NMR)(3rd trimester of pregnancy and D2-Day 366)
- Secretor status genotyping(3rd trimester pregnancy and Day 60 postpartum)
- Maternal fasting and postprandial blood sugar(3rd trimester of pregnancy and Day 3-7)
- Human Milk Transcriptomics(3 and 6 months postpartum)
- Microbiota(3rd trimester pregnancy and Day 2-Day 366 postpartum)
- Proteome(Day 2-Day 366 postpartum)
- Lipidome(Day 2-Day 366 postpartum)
- Metabolome by MS(Day 2-Day 366 postpartum)