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| Name | Class |
|---|---|
| Nutricia Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Key Group of interest | Active Comparator | Subjects who started test product / control product 1 / control product 2 by 1-month of age |
|
| Other-fed Group | Active Comparator | Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding |
|
| Breast Fed Reference Group | Active Comparator | Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product | Other | Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain per day | Weight gain per day from randomisation until 17 weeks of age. | 17 weeks |
| Total weight gain | Total weight gain from birth until 12 months of age | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 17 weeks |
| Skin-fold thickness |
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Inclusion Criteria:
Exclusion criteria for the pregnant women/parents:
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.
Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
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
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:
Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
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
Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
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)
Infants with any history of or current participation in any other study involving investigational or marketed products.
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| Name | Affiliation | Role |
|---|---|---|
| Oon Hoe Teoh, Dr, MD | KK Women's and Children's Hospital | Principal Investigator |
| Yap Seng Chong, A/Prof, MD | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital, Singapore | Singapore | 119228 | Singapore | |||
| KK Women's and Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41189742 | Derived | van der Merwe LF, Mulder KA, van Oudenhoven FM, Shek LP, Teoh OH, Pang WW. Mixed Milk Feeding Patterns and Growth Outcomes During the First Year of Life in Asian Infants: Application of Predefined Feeding Clusters to Test Associations. Curr Dev Nutr. 2025 Oct 3;9(11):107565. doi: 10.1016/j.cdnut.2025.107565. eCollection 2025 Nov. |
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| Control Product 1 | Other | Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS |
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| Control Product 2 | Other | Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides. |
|
Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age |
| 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 | 24 months |
| Singapore |
| 229899 |
| Singapore |