Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT04960670

LIMIT Early Adiposity Rebound in Children

LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
University of Pavia · Academic / Other
Sex
All
Age
1 Day – 48 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEREvaluation of microbiome and maternal/infant lifestyleIdentification of the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with adiposity rebound vs children with early adiposity rebound.

Timeline

Start date
2021-12-01
Primary completion
2025-12-31
Completion
2026-12-31
First posted
2021-07-14
Last updated
2021-07-14

Source: ClinicalTrials.gov record NCT04960670. Inclusion in this directory is not an endorsement.