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
131
PAS Research
Tampa, Florida, United States
Weight gain
Change grams per day
Time frame: 16 weeks
Mean stool consistency
1= watery, 2= runny / soft, 3= mushy / soft, 4= formed soft, 5= hard
Time frame: 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: 16 weeks
Mean gassiness score
0= no gas, 1= slight amount of gas, 2= moderate amount of gas, 3= excessive amount of gas
Time frame: 16 weeks
Mean interleukin - 6 Concentration
IL - 6 ng/ml
Time frame: 16 weeks
Mean interleukin - 10 Concentration
IL - 10 pg/ml
Time frame: 16 weeks
Mean tumor necrosis factor alpha concentration
TNF - alpha pg/ml
Time frame: 16 weeks
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