Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- infant weight
研究概览
简要总结
The goal of this observational study is to investigate the concentrations of leptin, insulin, liver expressed antimicrobial peptide 2 (LEAP2), and cortisol in plasma and breast milk and their relationship with eating behavior, growth, adiposity and with the levels of these hormones in infants, comparing mothers with normal weight and with pre-pregnancy overweight/obesity. The main question[s] it aims to answer are:
- Are maternal hormones associated with child growth and adiposity
- Are maternal hormone receptors associated with child growth and adiposity
- Are infant hormones and their receptors associated with child growth and adiposity
- Are maternal and infant hormones and their receptors associated with child eating behavior Participants will provide milk and blood samples. Researchers will compare mothers with normal weight and with pre-pregnancy overweight/obesity to see if there are differences in child growth and adiposity .
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
- •Lactating women with pre-pregnancy normal weight and overweight or obesity as described by the World Health Organization.
排除标准
- •Diabetes (Type I or II or gestational)
- •Multiple pregnancy
- •Hypertensive disorders during pregnancy
- •Delivery of pre-term infant (<37 weeks).
结局指标
主要结局
infant weight
时间窗: from birth to 2 years old
weight in kilograms
infant height
时间窗: from birth to 2 years old
height in centimeters
infant body mass index (BMI)
时间窗: from birth to 2 years old
weight and height will be combined to report BMI in kg/m\^2
infant upper arm circumference
时间窗: from birth to 2 years old
upper arm circumference in centimeters
infant skinfold thickness
时间窗: from birth to 2 years old
skinfold thickness in centimeters
infant blood leptin concentration
时间窗: six months old
blood leptin concentration (ng/ml)
infant blood cortisol concentration
时间窗: six months old
blood cortisol concentration (ug%)
infant saliva cortisol concentration
时间窗: six months old
saliva cortisol (ug%)
infant blood insulin concentration
时间窗: six months old
blood insulin concentration (uU/ml)
infant insulin receptor gene expression in peripheral blood mononuclear cells
时间窗: six months old
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant leptin receptor gene expression in peripheral blood mononuclear cells
时间窗: six months old
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells
时间窗: six months old
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant blood LEAP2 concentration
时间窗: six months old
blood LEAP2 concentration (pg/ml)
infant eating behavior assessed in a Taste acceptance test
时间窗: at 18 month od
Outcome Measures Infant taste acceptance was assessed using two complementary measures: an Ingestion Ratio (IR) and a Liking Ratio (LR). Sweet and fat taste acceptance were evaluated using a lactose solution (0.2 M) and a fat emulsion (3.5% w/v), respectively, with water used as a reference. During each test, infants were sequentially offered bottles containing water and the tastant. Intake volume was determined by weighing bottles before and after ingestion. The IR was calculated as the volume of tastant consumed divided by the total volume of tastant plus water consumed, allowing comparison across infants by accounting for individual differences in sucking behavior. The LR was based on a blinded experimenter's assessment of the infant's overall behavioral response using a standardized 5-point scale ranging from strong rejection to strong acceptance. Both ratios ranged from 0 to 1, with 0.5 indicating indifference relative to water.
次要结局
- maternal milk insulin concentration(15 days, three and six months postpartum)
- maternal leptin receptor gene expression in peripheral blood mononuclear cells(15 days, three and six months postpartum)
- maternal blood insulin concentration(15 days, three and six months postpartum)
- maternal milk cortisol concentration(15 days, three and six months postpartum)
- maternal blood cortisol concentration(15 days, three and six months postpartum)
- maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells(15 days, three and six months postpartum)
- maternal milk LEAP2 concentration(15 days, three and six months postpartum)
- maternal milk leptin concentration(15 days, three and six months postpartum)
- maternal blood LEAP2 concentration(15 days, three and six months postpartum)
- maternal blood leptin concentration(15 days, three and six months postpartum)
- maternal insulin receptor gene expression in peripheral blood mononuclear cells(15 days, three and six months postpartum)