LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Infant's intestinal microbiome assessment - microbial diversity
研究概览
简要总结
Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in "the first 1,000 days" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary/lifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset.
LIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model.
The study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.
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
- 1 Day 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •i) Infants with genetic/congenital diseases; ii) Infants selected for another clinical study; iii) Infants hospitalized immediately after birth; iv) Presence of gestational diabetes; v) Presence of hyperthyroidism during pregnancy; vi) Parents refusing to sign the informed consent.
结局指标
主要结局
Infant's intestinal microbiome assessment - microbial diversity
时间窗: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Infant's intestinal microbiome assessment - relative abundance
时间窗: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by identifying the relative abundance of the dominant microbes.
Infant's intestinal microbiome assessment - inter-individual variation
时间窗: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
次要结局
- Predictive model(48-60 month)
- Infant intestinal microbiome and maternal dietary habits(0-48 month)
- Infant intestinal microbiome and dietary habits(0-48 month)
- Infant intestinal microbiome and pre-gestational weight status(0-48 month)
- Infant intestinal microbiome and maternal weight gain(0-48 month)
- Infant intestinal microbiome and maternal physical activity(0-48 month)
- Infant intestinal microbiome and mode of delivery(0-48 month)
- Infant intestinal microbiome and lactation(0-48 month)
- Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure(0-48 month)
- Adiposity rebound identification(0-48 month)
- Infant intestinal microbiome and infant sleeping habits(0-48 month)