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

Completed

• Conditions: Healthy

• Registration Number: NCT02594683
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Brief 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

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2019-09-12
• Study Completion: 2020-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	up to 5 years of age

Secondary Outcome Measures

Name	Time	Method
Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)	up to 5 years of age
Z-scores of Weight-for-age	up to 5 years of age
Z-scores of Weight-for-height	up to 5 years of age
Z-scores of BMI-for-age	up to 5 years of age
Z-scores of Height-for-age	up to 5 years of age
Z-score of Head circumference-for-age	up to 5 years of age
Z-score of Skinfold-for-age (subscapular, triceps)	up to 5 years of age
Z-score of Mid-upper-arm-circumference-for-age	up to 5 years of age

Trial Locations

Locations (2)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore