HealthyVenusNCT01609634
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
A study testing Test Product in people with Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 2 sitesSingapore
- Study dates
- Jul 2012to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital, Singapore
Singapore, 119228
KK Women's and Children's Hospital
Singapore, 229899
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Test Product, Control Product 1, Control Product 2
- Keywords
- Healthy, Term infants, Growth, Body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ProductOther
Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
Control Product 1Other
Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
Control Product 2Other
Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
| Study group | Role | What they receive |
|---|---|---|
| Key Group of interest | Active comparator | Subjects who started test product / control product 1 / control product 2 by 1-month of age Receives: Other: Test Product |
| Other-fed Group | Active comparator | Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding Receives: 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. Receives: Other: Control Product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain per day
Weight gain per day from randomisation until 17 weeks of age.
Measured: 17 weeks
Total weight gain
Total weight gain from birth until 12 months of age
Measured: 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.
Measured: 24 months
Secondary outcomes (3)
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
Measured: 17 weeks
Skin-fold thickness
Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Research
- Responsible party
- Sponsor
- Investigators
- Oon Hoe Teoh, Dr, MD, Principal investigator, KK Women's and Children's HospitalYap Seng Chong, A/Prof, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609634
- Sponsor's protocol ID
- EBB15GL04184
- Acronym
- Venus
- Status last verified
- Oct 2021
- First submitted
- 29 May 2012
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41189742
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01609634
- Acronym / sponsor ID
- Venus / EBB15GL04184
- Conditions
- Healthy
- Keywords
- Healthy, Term infants, Growth, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Research
- Study start
- Jul 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Key Group of interest | Active comparator | Other: Test ProductSubjects who started test product / control product 1 / control product 2 by 1-month of age |
| Other-fed Group | Active comparator | Other: Control Product 1Subjects who started test product / control product 1 / control product 2 and continued on breast-feeding |
| Breast Fed Reference Group | Active comparator | Other: Control Product 2Subjects who are exclusively breast-fed up to 4 months of age and not started on test product / control product 1 / control product 2. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test ProductStandard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis® | Other | Key Group of interest |
| Control Product 1Control group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS | Other | Other-fed Group |
| Control Product 2Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides. | Other | Breast Fed Reference Group |
Primary outcome
Weight gain per day
Time frame: 17 weeks
Weight gain per day from randomisation until 17 weeks of age.
Total weight gain
Time frame: 12 months
Total weight gain from birth until 12 months of age
Sum of skin fold thicknesses
Time frame: 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.
3 secondary outcomes
Recumbent length, head circumference, mid-upper arm circumference, skin folds
Time frame: 17 weeks
Skin-fold thickness
Time frame: 12 months
Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Derived from this study: PubMed 41189742van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oon Hoe Teoh, Dr, MD principal investigator
KK Women's and Children's Hospital
Yap Seng Chong, A/Prof, MD principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Product in people with Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain per day (time frame: 17 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.