The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).
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 study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
180
Study infant formula for term infants containing OPO and CPP
JiangNan Street Community Health Service Center, WuCheng District
Jinhua, China
QiuBin Street Community Health Service Center, WuCheng District
Jinhua, China
Stool characteristics
Infant Stool Form Scale to measure stool consistency, amount and color (Bekkali et al, 2009): 4-point scale as watery (A) soft (B) formed (C) or hard (D)
Time frame: 1 month to 5 months
Formula intake and tolerance (24 hour dietary recall)
ml /day
Time frame: 2 months to 5 months
Medically-diagnosed adverse events collected throughout the study period
frequency
Time frame: 1 month to 5 months
Crying and sleep tracking (24 hours recall)
frequency
Time frame: 2 months to 5 months
Gastrointestinal tract discomfort
frequency of parents observed and documented GI tract discomfort
Time frame: 1 month to 5 months
Anthropometric parameters on growth
Achieved body length (CM)
Time frame: 1month to 5 months
Anthropometric parameters on growth
Achieved head circumferences (CM)
Time frame: 1month to 5 months
Anthropometric parameters on growth
Achieved body weight (kg)
Time frame: 1month to 5 months
Bone Speed Of Sound
Ultrasound Bone Densitometer (BMD-A3)
Time frame: at 1 month and 5 months
Anthropometric parameters on growth
Rate of gain (%) on achieved head circumferences
Time frame: 1month to 5 months
Anthropometric parameters on growth
Rate of gain (%) on achieved body weight
Time frame: 1month to 5 months
Anthropometric parameters on growth
Rate of gain (%) on achieved body length
Time frame: 1month to 5 months
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