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Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02950740
Acronym
Nutrilife
Enrollment
228
Registered
2016-11-01
Start date
2015-10-31
Completion date
2016-03-31
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Nutrition Disorders

Keywords

malnutrition

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.

Interventions

None listed

Sponsors

Faculdade de Medicina do ABC
CollaboratorOTHER
Universidade Federal do Rio Grande do Norte
CollaboratorOTHER
Universidade Federal do Triangulo Mineiro
CollaboratorOTHER
Federal University of Health Science of Porto Alegre
CollaboratorOTHER
Danone Early Life Nutrition Brazil
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Child Nutritional disordersup to two monthsObesity, overweight

Secondary

MeasureTime frameDescription
Levels of blood cellsup to three monthslaboratory parameters: blood count
Fatty acids compositionup to three monthsanalysis in erythrocytes
Microbiotaup to three monthsDiversity of fecal microbiota
deficiency of mineralsup to three monthslaboratory parameters: calcium, zinc, selenium
Deficiency of retinolup to three monthsLaboratory parameters: blood retinol
Levels of alkaline phosphataseup to three monthsLaboratory parameters:alkaline phosphatase
Levels of ferritinup to three monthsLaboratory parameters: ferritin
Deficiency of vitamin Dup to three monthsLaboratory parameters:level of vitamin D
Food intakeup to two monthsDirect food weighing
Problems in child growthup to two monthsstunting

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026