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NCT Number: NCT02594683

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

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Key information

Conditions

Healthy

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: up to 5 years of age

Secondary outcomes

  1. Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)

    Time frame: up to 5 years of age

  2. Z-scores of Weight-for-age

    Time frame: up to 5 years of age

  3. Z-scores of Weight-for-height

    Time frame: up to 5 years of age

  4. Z-scores of Height-for-age

    Time frame: up to 5 years of age

  5. Z-scores of BMI-for-age

    Time frame: up to 5 years of age

  6. Z-score of Head circumference-for-age

    Time frame: up to 5 years of age

  7. Z-score of Mid-upper-arm-circumference-for-age

    Time frame: up to 5 years of age

  8. Z-score of Skinfold-for-age (subscapular, triceps)

    Time frame: up to 5 years of age

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

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

Registry information

Official study 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

Acronym: VenusFU

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Nov 3, 2015
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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