In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
345
infant formula based on hydrolysed protein
infant formula based on intact protein
Department of Nutrition and Dietetics, University of Thessaly
Trikala, Thessaly, Greece
Harokopio University
Athens, Greece
Department of Nutritional Sciences, International Hellenic University
Thessaloniki, Greece
weight gain
weight gain in g/day
Time frame: until 17 weeks of age
Weight
Weight in g
Time frame: until 17 weeks of age
Length
length in cm
Time frame: until 17 weeks of age
head circumference
head circumference in cm
Time frame: until 17 weeks of age
BMI
BMI in kg/m2
Time frame: until 17 weeks of age
WAZ
weight-for-age Z-score
Time frame: until 17 weeks of age
LAZ
length-for-age Z-score
Time frame: until 17 weeks of age
WHZ
weight-for-height Z-score
Time frame: until 17 weeks of age
BMI-for-age Z-score
BMI-for-age Z-score
Time frame: until 17 weeks of age
head circumference-for-age Z-score
head circumference-for-age Z-score
Time frame: until 17 weeks of age
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