Healthy
Conditions
Keywords
Healthy, Term infants, Growth, Body composition
Brief summary
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
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.
Interventions
OTHERTest Product
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
OTHERControl Product 1
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
OTHERControl Product 2
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
Sponsors
Nutricia Research
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
Yes
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 (3rd to 90th percentile according to applicable growth charts) 4. Head circumference at birth within normal range (3rd to 90th percentile of the chart) 5. Chinese, Malay, or Indian ethnicity 6. Written informed consent from parent(s) 7. 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 are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation. 2. Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV) 3. 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 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain per day | 17 weeks | Weight gain per day from randomisation until 17 weeks of age. |
| Total weight gain | 12 months | Total weight gain from birth until 12 months of age |
| Sum of skin fold thicknesses | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recumbent length, head circumference, mid-upper arm circumference, skin folds | 17 weeks | 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 | 12 months | 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 | 24 months | Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age |
Countries
Singapore
Outcome results
None listed