Clinical trial

LIMIT Early Adiposity Rebound in Children

Opening soon · Not applicable · 0 countries · Registry ID NCT04960670

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age1 Day to 48 Months

SexAll

Healthy volunteersAccepted

ConditionChildhood Obesity, Life Style, Intestinal Microbiome

Full registry criteria

* Inclusion criteria: i) Infants of both sexes born to vaginal/caesarean delivery; ii) Gestational age: 37-42 weeks; iii) Italian-speaking parent; iv) 7 Ability of the parent/guardian to give informed consent; v) Ability of the mother to answer questionnaires. * 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.

Treatments and study arms

Evaluation of microbiome and maternal/infant lifestyle

Other

Identification 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.

Primary outcomes

Infant's intestinal microbiome assessment - relative abundance0-48 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 - microbial diversity0-48 month

To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.

Infant's intestinal microbiome assessment - inter-individual variation0-48 month

To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.

Study locations

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No public site location was included in this record. Check the original registry for updates.