HealthyVenusFUNCT02594683
A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition
An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Singapore.
Trial summary
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 359 participants
- Where
- 2 sitesSingapore
- Study dates
- Aug 2015to Dec 2020
- Phase
- Observational
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group
Who may be able to join
- Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group
- Written informed consent from parent(s) or legally acceptable representatives
Who cannot join
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital, Singapore
Singapore, 119074
KK Women's and Children's Hospital
Singapore, 229899
About this study
Official title: A Follow-up Study of a Randomised, Controlled, Study to Investigate the Effects of a New Infant Formula Given in the First 12 Months of Life on Growth and Body Composition up to 5 Years of Age
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age
Read the detailed description
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age. Participants from Venus study will be invited to participate in this follow-up study.
Hypothesis: Significant difference in body mass index (BMI) development for subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the control product scGOS/lcFOS and standard formula. No significant difference in growth of subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the breast-feeding reference group.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Key Group of Interest | Exclusively formula fed subjects since 1 month of age | |
| Other-Fed Group | Mixed feeding of formula and breast milk | |
| Breastfeeding Group | Exclusively breastfeeding at least until 4 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Measured: up to 5 years of age
Secondary outcomes (8)
Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)
Measured: up to 5 years of age
Z-scores of Weight-for-age
Measured: up to 5 years of age
Z-scores of Weight-for-height
Measured: up to 5 years of age
Z-scores of Height-for-age
Measured: up to 5 years of age
Z-scores of BMI-for-age
Measured: up to 5 years of age
Z-score of Head circumference-for-age
Measured: up to 5 years of age
Z-score of Mid-upper-arm-circumference-for-age
Measured: up to 5 years of age
Z-score of Skinfold-for-age (subscapular, triceps)
Measured: up to 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startAug 2015
- Primary completion12 Sep 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oon Hoe Teoh, MBBS, Principal investigator, KK Women's and Children's HospitalJian Yi Soh, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594683
- Sponsor's protocol ID
- EBB15GL04185
- Acronym
- VenusFU
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2015
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 Follow-up Study of a Randomised, Controlled, Study to Investigate the Effects of a New Infant Formula Given in the First 12 Months of Life on Growth and Body Composition up to 5 Years of Age
- ClinicalTrials.gov ID
- NCT02594683
- Acronym / sponsor ID
- VenusFU / EBB15GL04185
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, KK Women's and Children's Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 3 Nov 2015 (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.
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age
Detailed description
A follow-up study of a randomised, controlled, study to investigate the effects of a new infant formula given in the first 12 months of life on growth and body composition up to 5 years of age. Participants from Venus study will be invited to participate in this follow-up study.
Hypothesis: Significant difference in body mass index (BMI) development for subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the control product scGOS/lcFOS and standard formula. No significant difference in growth of subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the breast-feeding reference group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Key Group of Interest | – | –Exclusively formula fed subjects since 1 month of age |
| Other-Fed Group | – | –Mixed feeding of formula and breast milk |
| Breastfeeding Group | – | –Exclusively breastfeeding at least until 4 months of age |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group
Key inclusion criteria (2 listed)
- Participation in the intervention period of VENUS study until 12 months of age or participation in the VENUS study as breast-fed reference group
- Written informed consent from parent(s) or legally acceptable representatives
Key exclusion criteria (1 listed)
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Mass Index (BMI)
Time frame: up to 5 years of age
8 secondary outcomes
Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)
Time frame: up to 5 years of age
Z-scores of Weight-for-age
Time frame: up to 5 years of age
Z-scores of Weight-for-height
Time frame: up to 5 years of age
Z-scores of Height-for-age
Time frame: up to 5 years of age
Z-scores of BMI-for-age
Time frame: up to 5 years of age
Z-score of Head circumference-for-age
Time frame: up to 5 years of age
Z-score of Mid-upper-arm-circumference-for-age
Time frame: up to 5 years of age
Z-score of Skinfold-for-age (subscapular, triceps)
Time frame: up to 5 years of age
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.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, MBBS principal investigator
KK Women's and Children's Hospital
Jian Yi Soh, MBBS 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?
An observational study of 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 2 inclusion and 1 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?
Body Mass Index (BMI) (time frame: up to 5 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.