LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- University of Pavia
- Enrollment
- 150
- Primary Endpoint
- Infant's intestinal microbiome assessment - microbial diversity
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Infant's intestinal microbiome assessment - microbial diversity
Time Frame: 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
Time Frame: 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
Time Frame: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
Secondary Outcomes
- 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)