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

Not Applicable

Completed

• Conditions: Child Nutrition Sciences
• Interventions: Other: Cow's milk-based formula; Other: Cow's milk-based formula with added nutrients

• Registration Number: NCT02776592
• Lead Sponsor: Mead Johnson Nutrition

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.

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 Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2016-07-20
• Primary Completion: 2016-12-23
• Study Completion: 2016-12-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Cow's milk-based formula	A cow's milk-based formula
Experimental	Cow's milk-based formula with added nutrients	A cow's milk-based formula with added nutrients

Primary Outcome Measures

Name	Time	Method
Change in Working Memory Capacity	Up to 24 weeks	Recall of variable sequences

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Center Fima Lifshitz - Federal University of Bahia; 🇧🇷 Salvador, Bahia, Brazil