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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 359
- Locations
- 2
- Primary Endpoint
- Body Mass Index (BMI)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Years to 5 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Body Mass Index (BMI)
Time Frame: up to 5 years of age
Secondary Outcomes
- 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)