New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
NCT ID: NCT01609634
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
541 participants
INTERVENTIONAL
2012-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Key Group of interest
Subjects who started test product / control product 1 / control product 2 by 1-month of age
Test Product
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
Other-fed Group
Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding
Control Product 1
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
Breast Fed Reference Group
Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2.
Control Product 2
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
Interventions
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Test Product
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
Control Product 1
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
Control Product 2
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
Eligibility Criteria
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Inclusion Criteria
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
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
5. Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
6. 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
7. Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
8. 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)
9. Infants with any history of or current participation in any other study involving investigational or marketed products.
28 Days
ALL
Yes
Sponsors
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Nutricia Research
INDUSTRY
Danone Asia Pacific Holdings Pte, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Oon Hoe Teoh, Dr, MD
Role: PRINCIPAL_INVESTIGATOR
KK Women's and Children's Hospital
Yap Seng Chong, A/Prof, MD
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital, Singapore
Singapore, , Singapore
KK Women's and Children's Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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EBB15GL04184
Identifier Type: -
Identifier Source: org_study_id