Overview

This trial is active, not recruiting.

Condition child nutrition sciences
Treatments cow's milk-based formula with added nutrients, cow's milk-based formula
Sponsor Mead Johnson Nutrition
Collaborator Federal University of Bahia
Start date July 2016
End date December 2016
Trial size 199 participants
Trial identifier NCT02776592, 6036

Summary

This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Arm
(Experimental)
A cow's milk-based formula with added nutrients
cow's milk-based formula with added nutrients
(Active Comparator)
A cow's milk-based formula
cow's milk-based formula

Primary Outcomes

Measure
Change in Working Memory Capacity
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Change in Motor Response Speeds
time frame: Up to 24 weeks
Change in Mental Response Speeds
time frame: Up to 24 weeks
Change in Retention of Visual Information
time frame: Up to 24 weeks
Change in Manipulation of Visual Information
time frame: Up to 24 weeks
Change in Child Behavior Checklist
time frame: Up to 24 weeks
Stool Consistency Assessment
time frame: 24 weeks
Systemic antibiotic Usage
time frame: 24 weeks
Missed days due to illness
time frame: 24 weeks
Body Weight
time frame: 24 weeks
Height
time frame: 24 weeks
Study Product Intake Assessment
time frame: 24 weeks
Complete Blood Count (CBC)
time frame: Up to 24 weeks
Blood Fatty Acids
time frame: Up to 24 weeks
Metabolite Biomarkers
time frame: Up to 24 weeks
Serum Phospholipids
time frame: Up to 24 weeks
Immune Markers
time frame: Up to 24 weeks
Medically-confirmed adverse events
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 4 years up to 5 years old.

Inclusion Criteria: - Health child, 4-5 years of age - Born as full-term (Gestational age of 37-42 weeks) - Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit - Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics - Signed informed consent Exclusion Criteria: - History or known or suspected cow milk protein intolerance - Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit - Serious concurrent illness that will interfere in the general management of the child - History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised - Child's z-score of weight for height at baseline is < -3 according to WHO criteria

Additional Information

Official title Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Description This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mead Johnson Nutrition.