Clinical trial NCT02594683: A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: National University Hospital, Singapore
name: KK Women's and Children's Hospital
First posted: 2015-11-03
Enrollment: 359
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: up to 5 years of age
Secondary outcomes:
measure: Sum of skin fold thicknesses (triceps, biceps, suprailiac, subscapular)
timeFrame: up to 5 years of age
measure: Z-scores of Weight-for-age
timeFrame: up to 5 years of age
measure: Z-scores of Weight-for-height
timeFrame: up to 5 years of age
measure: Z-scores of Height-for-age
timeFrame: up to 5 years of age
measure: Z-scores of BMI-for-age
timeFrame: up to 5 years of age
measure: Z-score of Head circumference-for-age
timeFrame: up to 5 years of age
measure: Z-score of Mid-upper-arm-circumference-for-age
timeFrame: up to 5 years of age
measure: Z-score of Skinfold-for-age (subscapular, triceps)
timeFrame: up to 5 years of age
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Oon Hoe Teoh, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Jian Yi Soh, MBBS
role: PRINCIPAL_INVESTIGATOR
References: