This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.
This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
541
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
National University Hospital, Singapore
Singapore, Singapore
KK Women's and Children's Hospital
Singapore, Singapore
Weight gain per day
Weight gain per day from randomisation until 17 weeks of age.
Time frame: 17 weeks
Total weight gain
Total weight gain from birth until 12 months of age
Time frame: 12 months
Sum of skin fold thicknesses
Sum of skin fold thicknesses: triceps, biceps, suprailiac, subscapular until 24 months of age in subjects receiving the test product 1, test product 2, or control product.
Time frame: 24 months
Recumbent length, head circumference, mid-upper arm circumference, skin folds
Recumbent length, head circumference, mid-upper arm circumference, skin folds gain per day for subjects receiving test product 1 or test product 2
Time frame: 17 weeks
Skin-fold thickness
Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age
Time frame: 12 months
Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold
Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age
Time frame: 24 months
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