New Infant Formula Trial in Healthy Term Chinese Subjects on Growth, Body Composition, Tolerance and Safety (Venus)

• Weight gain per day [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  Weight gain per day from randomisation until 17 weeks of age.
• Total weight gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Total weight gain from birth until 12 months of age
• Sum of skin fold thicknesses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  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.

• Recumbent length, head circumference, mid-upper arm circumference, skin folds [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  Recumbent length, head circumference, mid-upper arm circumference, skin folds gain per day for subjects receiving test product 1 or test product 2
• Skin-fold thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age
• Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age

This study is initiated to investigate the effect of a new infant formula in healthy term Chinese subjects on growth, body composition, tolerance and safety.

• Other: Standard infant formula/follow-on formula
  Standard infant formula/follow-on formula with added scGOS/lcFOS
• Other: Standard infant formula/follow-on formula
  Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
• Other: Standard infant formula/follow-on formula
  Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

• Active Comparator: Intervention group 1
  Intervention group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
  Intervention: Other: Standard infant formula/follow-on formula
• Active Comparator: Intervention group 2
  Intervention group 2: Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
  Intervention: Other: Standard infant formula/follow-on formula
• Placebo Comparator: Control group
  Control group: Standard infant formula/follow-on formula with added standard fat droplets and without specific prebiotic oligosaccharides.
  Intervention: Other: Standard infant formula/follow-on formula

Inclusion Criteria:

1. Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks)
2. Age ≤ 28 days
3. Birth weight within normal range for gestational age and sex (10th to 90th percentile according to applicable growth charts)
4. Chinese ethnicity, including both sets of parents and grandparents
5. Written informed consent from parent(s)
6. Currently reside in Singapore and with the intention to reside in Singapore for at least the next 2 years

Exclusion criteria for the pregnant women/parents:

1. Pregnant women / mothers who have taken prebiotic supplementation during the last 2 weeks prior to date of delivery
2. Pregnant women / mothers who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation.
3. Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
4. Pregnant women / mothers known to have other significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (including, but not limited to: placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement

5. Incapability of the parents to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

   Exclusion criteria for the subjects:

6. Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
7. Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
8. Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
9. Infants who received any other infant formula, except the infant formula given in between birth and the initial breast-feeding (maximum of 3 consecutive days)
10. Infants with any history of or current participation in any other study involving investigational or marketed products.