Effect of the Level of Dietary Protein on Infant Growth

Société des Produits Nestlé (SPN)405 enrolled

Overview

The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

405

Conditions

Infant Nutrition

Interventions

Standard infant formulaOTHER

From 3 to 12 months of age. As per standard requirement

Infant formula with different level of proteinsOTHER

From 3 to 12 months of age. As per standard requirement

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Gestational age at least 37 weeks * Singleton birth * Birth weight between 2500g and 4500g * Weight at enrolment is at or above the 5th percentile (CDC) * Infant has been exclusively formula fed for at least the last 14 days * Having obtained informed consent of legal representative Exclusion Criteria: * Congenital illness or malformation that affects infant feeding and/or growth * Significant pre-natal and/or post-natal disease * Suspected or confirmed allergy to cow milk protein * In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen) * Currently participating in another clinical trial

Locations (2)

The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa

Iowa City, Iowa, United States

Department of Pediatrics University of Oklahoma Health Sciences

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Mean weight gain

Time frame: 6 months

Data from ClinicalTrials.gov

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