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

The Effect of Feeding Infant Formula With Enriched Protein Fractions

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02433600

Enrollment

Registered

2015-05-05

Start date

2015-08-31

Completion date

2015-10-31

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Declarative Memory

Brief summary

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.

Interventions

OTHERCow's milk-based infant formula

OTHERCow milk-based infant formula with enriched protein fractions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 90 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Electroencephalogram response to stimuli	180 days of age
Achieved Length	52 weeks
Achieved Head Circumference	52 weeks
Formula Intake	52 weeks
Medically-confirmed Adverse Events	52 weeks
Achieved Weight	52 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026