NCT04960670Not yet recruiting
LIMIT Early Adiposity Rebound in Children
LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
Source: ClinicalTrials.gov · Last updated 14 Jul 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 10 Jun 2021
- Start date
- 1 Dec 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Pavia
- Diseases
- Obesity
- NCT number
- NCT04960670
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Dec 2021 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 1 day to 48 months · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.