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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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