Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers (Nutrilife)

Evaluation of Nutritional Status, Food Intake and Fecal Microbiota of 1-3 Year-old Children From Four Regions of Brazil

Food intake pattern and lifestyle are associated with the nutritional status and intestinal microbiota composition, and such factors are important for the proper growth and development during early childhood, as well as for the health throughout life. This cross-sectional and multicenter study will include a total of 200 children aged between 1-3 years, enrolled in early childhood public schools from different regions of Brazil (Santo André, Uberaba, Porto Alegre and Natal). Data on birth and gestational history will be collected in a form. Nutritional status will be assessed by determining the weight and height, with subsequent calculations and classification of nutritional indices. A single blood sample will be collected to investigate the blood levels of vitamins A and D, iron, calcium, alkaline phosphatase and zinc, and feces will be collected for intestinal microbiota analysis. Food intake will be assessed by direct weighing of food in 2 non-consecutive days. Considering the importance of a well-balanced diet and its effects on the child's growth, development and intestinal colonization, this study purpose is to investigate potential associations among food intake, nutritional status and intestinal microbiota of early childhood infants from four regions of Brazil.

Study Overview

• Status: Completed
• Conditions: Child Nutrition Disorders

Detailed Description

It is a cross-sectional and multicenter study to examine two hundred children aged between 1-3 years, duly enrolled under full-time regimen in public schools of the cities of Santo André (SP), Uberaba (MG), Porto Alegre (RS) and Natal (RN). The Principal Site of study will be Fundação de Medicina do ABC, located in the city of Santo André, while Universidade Federal do Triângulo Mineiro, Universidade Federal of Ciências da Saúde de Porto Alegre and Universidade Federal do Rio Grande do Norte will be the other Sites. For such purpose, fifty children from each Early Childhood Public School will be screened according to the inclusion criteria and invited to participate in the study. Each State may include more than one Institution, if required to reach the total number of children established previously.

After the authorization and signature of the Informed Consent Form - ICF - (Attachment I) are given by the mother or legal responsible, such person must go to the Institution on the scheduled date for the collection of a blood sample and to deliver of a stool sample, collected as per prior orientation. The interviewer shall complete a questionnaire to obtain information on the birth and gestational history and current information on the child. A single blood sample will be collected for analysis of vitamins A and D, calcium, iron, ferritin, hemoglobin, zinc, selenium, alkaline phosphatase and lipids (cholesterol - total and fractions - and triglycerides), and a stool sample will be collected for analysis of parasites and microbiota in the feces.

• Study Type: Observational
• Enrollment (Actual): 228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

200 children aged between 1-3 years, under full-time regimen in public schools of four cities of Brazil (Santo André, Uberaba, Porto Alegre and Natal). Fifty children of each city will be evaluated.

Description

Inclusion Criteria:

• Children aged between 1-3 years
• Enrolled under full-time regimen in public schools
• Without any acute infection at the time of data collection.

Exclusion Criteria:

• Any chronic disease or congenital malformation
• Use of antibiotics in the past 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Center 01 (SA); Toddlers from Santo André Early Childhood Public School
Center 02 (POA); Toddlers from Porto Alegre Early Childhood Public School
Center 03 (MG); Toddlers from Uberaba Early Childhood Public School
Center 04 (RN); Toddlers from Natal Early Childhood Public School

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Nutritional disorders	Obesity, overweight	up to two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of blood cells	laboratory parameters: blood count	up to three months
Fatty acids composition	analysis in erythrocytes	up to three months
Microbiota	Diversity of fecal microbiota	up to three months
deficiency of minerals	laboratory parameters: calcium, zinc, selenium	up to three months
Deficiency of retinol	Laboratory parameters: blood retinol	up to three months
Levels of alkaline phosphatase	Laboratory parameters:alkaline phosphatase	up to three months
Levels of ferritin	Laboratory parameters: ferritin	up to three months
Deficiency of vitamin D	Laboratory parameters:level of vitamin D	up to three months
Food intake	Direct food weighing	up to two months
Problems in child growth	stunting	up to two months

Collaborators and Investigators

• Sponsor: Danone Early Life Nutrition Brazil
• Collaborators: Universidade Federal do Rio Grande do Norte; Federal University of Health Science of Porto Alegre; Universidade Federal do Triangulo Mineiro; Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Child Nutrition Disorders
• Other Study ID Numbers: DanoneELN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO