Nutritional Status, Food Intake and Fecal Microbiota of Brazilians Toddlers

NCT02950740 | Completed DMC

• 1 other identifier: DanoneELN-01
• Study Type: observational
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Nutrition Disorders

Keywords

malnutrition

Outcome Measures

Primary Outcomes (1)

• Child Nutritional disorders

  Obesity, overweight

  up to two months

Secondary Outcomes (10)

• Levels of blood cells

  up to three months

• Fatty acids composition

  up to three months

• Microbiota

  up to three months

• deficiency of minerals

  up to three months

• Deficiency of retinol

  up to three months

Study Arms (4)

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

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (plasma, serum and erythrocytes Fecal sample

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Care Nutrition Science Manager

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share