Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

Completed

• Conditions: Child Nutrition Disorders

• Registration Number: NCT02950740
• Lead Sponsor: Danone Early Life Nutrition Brazil

Brief Summary

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.

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 Timeline

• Study Start: 2015-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-03-31
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-28
• Last Update Submitted: 2016-10-28
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child Nutritional disorders	up to two months	Obesity, overweight

Secondary Outcome Measures

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