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

NCT01609634 | Completed DMC

• 1 other identifier: EBB15GL04184
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Healthy; Term infants; Growth; Body composition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Recumbent length, head circumference, mid-upper arm circumference, skin folds

  17 weeks

• Skin-fold thickness

  12 months

• Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold

  24 months

Study Arms (3)

Key Group of interest

ACTIVE COMPARATOR

Subjects who started test product / control product 1 / control product 2 by 1-month of age

Other: Test Product

Other-fed Group

ACTIVE COMPARATOR

Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding

Other: Control Product 1

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.

Other: Control Product 2

Interventions

Test Product OTHER

Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®

Key Group of interest

Control Product 1 OTHER

Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS

Other-fed Group

Control Product 2 OTHER

Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

Breast Fed Reference Group

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• Nutricia Research: collaborator

Study Sites (2)

National University Hospital, Singapore

Singapore, 119228, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

• 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.

  PMID: 41189742 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2019
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)