- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594683
A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition (VenusFU)
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Singapore, Singapore, 119074
- National University Hospital, Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Key Group of Interest
Exclusively formula fed subjects since 1 month of age
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Other-Fed Group
Mixed feeding of formula and breast milk
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Breastfeeding Group
Exclusively breastfeeding at least until 4 months of age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index (BMI)
Time Frame: up to 5 years of age
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up to 5 years of age
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-scores of Weight-for-age
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-scores of Weight-for-height
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-scores of Height-for-age
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-scores of BMI-for-age
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-score of Head circumference-for-age
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-score of Mid-upper-arm-circumference-for-age
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Z-score of Skinfold-for-age (subscapular, triceps)
Time Frame: up to 5 years of age
|
up to 5 years of age
|
Collaborators and Investigators
Investigators
- Principal Investigator: Oon Hoe Teoh, MBBS, KK Women's and Children's Hospital
- Principal Investigator: Jian Yi Soh, MBBS, National University Hospital, Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EBB15GL04185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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