In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included \<2mo of age. An exploratory follow-up assessment will be done at the age of 2 and 3 years to study sustained health effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
456
infant formula and follow-on formula with bioactive ingredients
standard cows milk infant formula and follow-on formula
Harokopio University
Athens, Greece
International Hellenic University
Thessaloniki, Greece
University of Thessaly
Trikala, Greece
weight
weight for age, compared to WHO growth curve, for test group only
Time frame: until age of 6 months
infection-related morbidity episodes, parent-reported
number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group
Time frame: 6 - 12 months of age
weight
weight for age, compared to WHO growth curve, for control group
Time frame: until the age of 6 months
length
length in cm
Time frame: until the age of 6 months
head circumference
head circumference in cm
Time frame: until the age of 6 months
BMI
BMI in kg/m2
Time frame: until the age of 6 months
product tolerance: GI comfort
GI comfort questionnaire
Time frame: until the age of 6 months
product tolerance: stool frequency and consistency
stool frequency and consistency questionnaire
Time frame: until the age of 6 months
product tolerance: product intake
product intake (ml/feeding, ml/day)
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Time frame: until the age of 6 months
Duration of infection-related episodes
duration of parental-reported respiratory and gut infection-related symptoms in summed days
Time frame: 6 - 12 months of age
infection-related morbidity episodes, physician-diagnosed
number of physician-diagnosed respiratory and gut infection-related symptoms
Time frame: 6 - 12 months of age