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

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.

Study Overview

• Status: Completed
• Conditions: Child Nutrition Sciences
• Intervention / Treatment: Other: Cow's milk-based formula with added nutrients; Other: Cow's milk-based formula

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil
      • Research Center Fima Lifshitz - Federal University of Bahia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; A cow's milk-based formula with added nutrients	Other: Cow's milk-based formula with added nutrients
Active Comparator: Control; A cow's milk-based formula	Other: Cow's milk-based formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Working Memory Capacity	Recall of variable sequences	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessment of adaptive function	Up to 24 weeks
Stool Consistency Assessment		24 weeks
Systemic antibiotic Usage		24 weeks
Missed days due to illness		24 weeks
Body Weight		24 weeks
Height		24 weeks
Study Product Intake Assessment		24 weeks
Complete Blood Count (CBC)		Up to 24 weeks
Blood Fatty Acids		Up to 24 weeks
Metabolite Biomarkers		Up to 24 weeks
Serum Phospholipids		Up to 24 weeks
Immune Markers		Up to 24 weeks
Medically-confirmed adverse events		24 weeks

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: Federal University of Bahia
• Investigators: Study Director: Jon Vanderhoof, M.D., Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2016
• Primary Completion (Actual): December 23, 2016
• Study Completion (Actual): December 23, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Healthy Children
• Other Study ID Numbers: 6036 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO