A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.
This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a experimental infant formula, formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
260
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Norwich Pediatric Group
Norwich, Connecticut, United States
Aventiv Research
Grove City, Ohio, United States
Weight gain
g/d
Time frame: 16 weeks
Mean stool consistency
1= watery, 2= runny / soft, 3= musy / soft, 4= formed soft, 5= hard
Time frame: Monthly for 16 weeks
Mean fussiness score
0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal
Time frame: Monthly 16 weeks
Mean gassiness score
0= no gas, 1= slight amount of gas, 2= moderate amout of gas, 3= excessive amount of gas
Time frame: Monthly 16 weeks
Mean interleukin - 6 Concentration
IL - 6 ng/ml
Time frame: at 16 weeks
Mean interleukin - 10 Concentration
IL - 10 pg/ml
Time frame: at 16 weeks
Mean tumor necrosis factor alpha Concentration
TNF - alpha pg/ml
Time frame: at 16 weeks
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HMG Pediatrics at Medical Plaza
Bristol, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States