Impact of Infant Feeding on Newborn Metabolomic Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Metabolite patterns associated with different dietary regimens
研究概览
简要总结
The purpose of this study is the evaluation with untargeted modalities, of the urine metabolomic profile in a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional ingredients and a group of breast-fed infants.
详细描述
Metabolomics is of particular interest in the field of nutrition, since nutrients interact with a number of targets, metabolic pathways and functions.
A suitable biofluid to study nutrient intake is urine, which is the most commonly used biological sample for metabolomic analysis and can be collected with simple and non-invasive methods.
Up to now, no studies have investigated healthy term infants metabolome and its modulation according to different dietary regimens such as formula-feeding or breastfeeding.
The aim of this study is to evaluate, with untargeted modalities, the urine metabolomic profile of a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional ingredients and a group of breast-fed infants.
Formula-fed infants participate to PLA-LENI-09 study (NCT01197365). We have included also a control group of breast-fed infants, as, from a scientific point of view, they represent the "gold standard" and no data are available on their metabolomic profile.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants being exclusively either breastfed or formula-fed by the 21st day of life
- •Infants of both sexes born with natural or caesarian delivery
- •Gestational age between 37 and 42 completed weeks
- •Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
- •Single birth
- •Caucasian parents
排除标准
- •Infants with genetic and/or congenital diseases
- •Infants receiving antibiotic therapy
- •Infants with neonatal diseases requiring hospitalisation for longer than 7 days
- •Infants at risk for atopy and/or having familial history for atopy
- •Mothers with metabolic or chronic diseases
- •Infant selected for another clinical study
- •Parents refusing to sign a written informed consent
结局指标
主要结局
Metabolite patterns associated with different dietary regimens
时间窗: At enrolment, after 60 and 135 days of life
Urine will be analysed using 1H-NMR. Data will be analyzed through the use of software products to enable the discovery of hundreds of different metabolites involved in multiple pathways and connected with different conditions. The metabolites on which the univariate analysis will be performed are the most important revealed by the multivariate analysis (VIP variables) and Student's statistical test will be performed.
次要结局
未报告次要终点