NCT Number: NCT04960670
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.
Trial opening soon.
Get Notified1 day–48 month
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Time frame: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
Time frame: 0-48 month
To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and pre-gestational weight status in children showing early adiposity rebound and in those showing normal adiposity rebound. In brief, maternal height (cm) and pre-pregnancy weight will be registered to calculate pre-gestational body mass index (BMI, Kg/m2).
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and maternal weight gain (Kg) during pregnancy in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome, and maternal dietary habits in children showing early adiposity rebound and in those showing normal adiposity rebound. Dietary habits will be evaluated by using a previously validated questionnaire.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and maternal physical activity during pregnancy in children showing early adiposity rebound and in those showing normal adiposity rebound. Physical activity will be evaluated by using a previously validated questionnaire.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and mode of delivery (vaginal delivery vs. caesarean section delivery) in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and lactation (breastfeeding vs. formula feeding) in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and maternal EDCs exposure (e.g. BPA, phthalates) in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and dietary habits in children showing early adiposity rebound and in those showing normal adiposity rebound. Infant dietary habits will be evaluated by using a previously validated questionnaire.
Time frame: 0-48 month
To identify the longitudinal interplay between infant intestinal microbiome and sleeping habits, in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 48-60 month
To develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.
Contact information is provided by the study sponsor or research team.
Hellas Cena, Prof
CONTACT
Ilaria Di Napoli, Dr
CONTACT
University of Pavia
Other
LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
Acronym: LIMIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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