A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition (VenusFU)

October 14, 2021 updated by: Danone Asia Pacific Holdings Pte, Ltd.

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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

359

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital
      • Singapore, Singapore, 119074
        • National University Hospital, Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index (BMI)
Time Frame: up to 5 years of age
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

September 12, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

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

Other Study ID Numbers

  • EBB15GL04185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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