Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life

Exclusion Criteria

• •Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:
• •1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
• •2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy
• •3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
• •4. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
• •5. Received radiation therapy (eg. scannography or interventional radiology)
• •6. Participation in any other clinical trial prior to enrollment
• •7. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures