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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Declarative Memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cow's milk-based infant formula

Group Type ACTIVE_COMPARATOR

Cow's milk-based infant formula

Intervention Type OTHER

Cow milk-based infant formula with enriched protein fractions

Group Type EXPERIMENTAL

Cow milk-based infant formula with enriched protein fractions

Intervention Type OTHER

Interventions

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Cow's milk-based infant formula

Intervention Type OTHER

Cow milk-based infant formula with enriched protein fractions

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes