"Watch Your Baby Grow" Study (GRO)

• Intake and feeding behaviors [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]
  Intake and satiety behaviors measured during infant-led feeding conditions. Maternal reports of infant dietary history and maternal perception of infant behavior, using standardized questionnaires, will also be obtained.
• Genotype [ Time Frame: 2wks-18 months ] [ Designated as safety issue: No ]
  Saliva and stool samples will be collected and later genotyped.

The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.

This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.

• Growth
• Energy Balance

• Active Comparator: Type of Formula: CMF
  infant is randomized to feed standard cow milk formula during first year of life
  Intervention: Other: Type of Formula
• Experimental: Type of Formula: ePHF
  infant is randomized to feed extensively hydrolyzed infant formula during first year of life
  Intervention: Other: Type of Formula

• Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. Epub 2010 Dec 27.
• Mennella JA, Pepino MY, Reed DR. Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics. 2005 Feb;115(2):e216-22.
• Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91.
• Mennella JA, Forestell CA, Morgan LK, Beauchamp GK. Early milk feeding influences taste acceptance and liking during infancy. Am J Clin Nutr. 2009 Sep;90(3):780S-788S. Epub 2009 Jul 15.
• Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. Epub 2011 Feb 10.
• Trabulsi J, Schall JI, Ittenbach RF, Olsen IE, Yudkoff M, Daikhin Y, Zemel BS, Stallings VA. Energy balance and the accuracy of reported energy intake in preadolescent children with cystic fibrosis. Am J Clin Nutr. 2006 Sep;84(3):523-30.

Inclusion Criteria

1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
2. Birth weight between 2500 - 4500 grams.
3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
4. Mother must be 18 years or older.
5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.

Exclusion Criteria

1. Mother had gestational diabetes during pregnancy
2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.

• University of Delaware
• Children's Hospital of Philadelphia
• University of Wisconsin, Madison