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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Key Group of Interest<br>Exclusively formula fed subjects since 1 month of age | |
| Other-Fed Group<br>Mixed feeding of formula and breast milk | |
| Breastfeeding Group<br>Exclusively breastfeeding at least until 4 months of age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) |  | up to 5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Height-for-age |  | up to 5 years of age | 
| Z-scores of BMI-for-age |  | 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 |