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

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.

This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Test Product; Other: Control Product 1; Other: Control Product 2

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.

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore, 119228
    • National University Hospital, Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

   Exclusion criteria for the subjects:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Key Group of interest; Subjects who started test product / control product 1 / control product 2 by 1-month of age	Other: Test Product; Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
ACTIVE_COMPARATOR: Other-fed Group; Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding	Other: Control Product 1; Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
ACTIVE_COMPARATOR: 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.	Other: Control Product 2; Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: Nutricia Research
• Investigators: Principal Investigator: Oon Hoe Teoh, Dr, MD, KK Women's and Children's Hospital; Principal Investigator: Yap Seng Chong, A/Prof, MD, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2012
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 1, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Healthy; Body composition; Growth; Term infants
• Other Study ID Numbers: EBB15GL04184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO