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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomised, Controlled, Double-blind Trial to Investigate the Effects of a New Infant Formula in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety.

Conditions
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Healthy

Intervention / Treatment
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* Other: Test Product
* Other: Control Product 1
* Other: Control Product 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks) Age ≤ 28 days Birth weight within normal range for gestational age and sex (3rd to 90th percentile according to applicable growth charts) Head circumference at birth within normal range (3rd to 90th percentile of the chart) Chinese, Malay, or Indian ethnicity Written informed consent from parent(s) 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: 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.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Key Group of interest<br>Subjects who started test product / control product 1 / control product 2 by 1-month of age | Other: Test Product<br>* Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®<br>|
| Active Comparator: Other-fed Group<br>Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding | Other: Control Product 1<br>* Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS<br>|
| Active Comparator: Breast Fed Reference Group<br>Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2. | Other: Control Product 2<br>* Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Term infants, Growth, Body composition