Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children

NCT02776592 | Completed

• 1 other identifier: 6036
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Nutrition Sciences

Keywords

Healthy Children

Outcome Measures

Primary Outcomes (1)

• Change in Working Memory Capacity

  Recall of variable sequences

  Up to 24 weeks

Secondary Outcomes (17)

• Change in Motor Response Speeds

  Up to 24 weeks

• Change in Mental Response Speeds

  Up to 24 weeks

• Change in Retention of Visual Information

  Up to 24 weeks

• Change in Manipulation of Visual Information

  Up to 24 weeks

• Change in Child Behavior Checklist

  Up to 24 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

A cow's milk-based formula with added nutrients

Other: Cow's milk-based formula with added nutrients

Control

ACTIVE COMPARATOR

A cow's milk-based formula

Other: Cow's milk-based formula

Interventions

Cow's milk-based formula with added nutrients OTHER

Experimental

Cow's milk-based formula OTHER

Control

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mead Johnson Nutrition: lead
• Federal University of Bahia: collaborator

Study Sites (1)

Research Center Fima Lifshitz - Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Location

Study Officials

• Jon Vanderhoof, M.D.

  Mead Johnson Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 18, 2016
• Study Start: July 20, 2016
• Primary Completion: December 23, 2016
• Study Completion: December 23, 2016
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)