Infant Nutrition
Conditions
Keywords
Infant formula, Protein metabolism
Brief summary
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.
Interventions
From 3 to 12 months of age. As per standard requirement
OTHERInfant formula with different level of proteins
From 3 to 12 months of age. As per standard requirement
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean weight gain | 6 months |
Countries
United States
Outcome results
None listed