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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02594683

Acronym

VenusFU

Enrollment

359

Registered

2015-11-03

Start date

2015-08-31

Completion date

2020-12-31

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 5 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Body Mass Index (BMI)	up to 5 years of age

Secondary

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

Countries

Singapore

Outcome results