The Effect of Feeding Infant Formula With Enriched Protein Fractions

Mead Johnson Nutrition

Status: Completed

Conditions: Cognitive Ability, General

Treatments: Dietary Supplement: Enriched Protein Fractions; Dietary Supplement: Protein Fractions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02274883

6027

Details and patient eligibility

About

This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Full description

To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Enrollment: 451 patients

Sex: All

Ages: 10 to 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 10-14 days of age
• Exclusively formula-fed
• Singleton birth
• Gestational age of 37-42 weeks
• Birth weight of 2500g to 4000g
• Signed Informed Consent Form

Exclusion criteria

• History of underlying metabolic or chronic disease
• Congenital malformation
• Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
• Evidence of feeding difficulties or intolerance
• Immunocompromised
• Head/brain disease/injury

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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451 participants in 2 patient groups

Enriched Protein Fractions

Experimental group

Description:

This group is given Infant formula with enriched protein fractions.

Treatment:

Dietary Supplement: Enriched Protein Fractions

Protein Fractions

Active Comparator group

Description:

This group is given Infant formula with protein fractions.

Treatment:

Dietary Supplement: Protein Fractions