LIMIT Early Adiposity Rebound in Children

NCT04960670 | Not Yet Recruiting

• 1 other identifier: 10062021
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Childhood Obesity; Life Style; Intestinal Microbiome

Keywords

childhood obesity; maternal lifestyle; gut microbiome; adiposity rebound; fetal programming; first thousand days; pregnancy; breastfeeding; children nutrition; endocrine disruptors chemicals

Outcome Measures

Primary Outcomes (3)

• Infant's intestinal microbiome assessment - relative abundance

  To investigate the infant's intestinal microbiome development (0-48 months) by identifying the relative abundance of the dominant microbes.

  0-48 month

• Infant's intestinal microbiome assessment - microbial diversity

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

  0-48 month

• Infant's intestinal microbiome assessment - inter-individual variation

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

  0-48 month

Secondary Outcomes (11)

• Adiposity rebound identification

  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 dietary habits

  0-48 month

• Infant intestinal microbiome and maternal physical activity

  0-48 month

Study Arms (1)

Dyads

Mother/infant pairs will be evaluated for anthropometric parameters, prenatal (dietary/lifestyle maternal factors)/postnatal determinants (type of feeding, sleep patterns, speed of growth) before discharge and after different follow-up after birth. Infant urinary and stool samples will be collected and stored. The infant adiposity rebound will be monitored.

Other: Evaluation of microbiome and maternal/infant lifestyle

Interventions

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.

Dyads

Eligibility Criteria

• Age: 1 Day - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mother and infant pairs.

Sponsors & Collaborators

• University of Pavia: lead

Biospecimen

Retention: SAMPLES WITH DNA

* Infant stool samples for the gut microbiota analysis * Maternal blood samples for nutritional status evaluation. * Maternal urinary samples for endocrine disruptors chemicals. All biological samples will be collected and stored at -80°C until the analysis.

MeSH Terms

Conditions

Pediatric Obesity; Breast Feeding

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Rachele De Giuseppe, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Di Napoli, Dr

CONTACT

+390382987536; ilaria.dinapoli@unipv.it

Hellas Cena, Prof

CONTACT

+390382987542; hellas.cena@unipv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 14, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share