The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US

The Effect of Feeding Infant Formula With Enriched Protein Fractions

This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.

Study Overview

• Status: Terminated
• Conditions: Declarative Memory
• Intervention / Treatment: Other: Cow's milk-based infant formula; Other: Cow milk-based infant formula with enriched protein fractions

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Kannapolis, North Carolina, United States, 28081
      • University or North Carolina Nutrition Research Instutite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Singleton, 0-90 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
• Parent or legally authorized representative attending study visits reads, understands, and speaks English
• Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
• Feeding difficulties or formula intolerance
• Infant born small for gestational age
• Infant born from a mother who was diabetic at childbirth
• History of seizures or neurological disorders or infant with known head/brain disease/injury

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cow's milk-based infant formula	Other: Cow's milk-based infant formula
Experimental: Cow milk-based infant formula with enriched protein fractions	Other: Cow milk-based infant formula with enriched protein fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sequence Recall using 3-dimensional props	365 days of age

Secondary Outcome Measures

Outcome Measure	Time Frame
Electroencephalogram response to stimuli	180 days of age
Sequence Recall using 3-dimensional props	300 days of age
Infant Behavior Questionnaire Revised, Short	240 days of age
MacArthur-Bates Communication Development Inventory	365 days of age
Bayley Scales of Infant and Toddler Development, Third Edition	365 days of age
Achieved Weight	52 weeks
Achieved Length	52 weeks
Achieved Head Circumference	52 weeks
Formula Intake	52 weeks
Medically-confirmed Adverse Events	52 weeks

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 6035