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

Mead Johnson Nutrition

Status: Terminated

Conditions: Declarative Memory

Treatments: Other: Cow's milk-based infant formula; Other: Cow milk-based infant formula with enriched protein fractions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02433600

6035

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: Under 90 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2 participants in 2 patient groups

Cow's milk-based infant formula

Active Comparator group

Treatment:

Other: Cow's milk-based infant formula

Cow milk-based infant formula with enriched protein fractions

Experimental group

Treatment:

Other: Cow milk-based infant formula with enriched protein fractions