ProtEUs
Completed
- Conditions
- Infant formula, KunstvoedingProtein intake, eiwitinnameBody Composition, lichaamssamenstelling
- Registration Number
- NL-OMON28714
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 291
Inclusion Criteria
Born at term (born >37 weeks of gestation)
-Birth weight between p3 and p97 (WHO growth curves birth to 6 months of age)
Exclusion Criteria
-Multiple birth
-Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (growth), as per investigator’s clinical judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to investigate equivalence of weight gain from randomisation until 17 weeks of age in infants receiving the formula with an optimized amino acid composition and a lower total protein content compared to infants receiving the control product: a formula with a standard amino acid composition and protein content.
- Secondary Outcome Measures
Name Time Method Body composition: <br /><br>-Body fat percentage<br /><br>-Fat-free mass (FFM)<br /><br>-Fat mass (FM)<br /><br>-Fat-free mass index (FFMI)<br /><br>-Fat mass index (FMI)<br /><br>-Skinfold thickness <br /><br>Plasma concentrations of: <br /><br>-Total IGF-1<br /><br>-Glucose<br /><br>-Insulin<br /><br>-IGFBP1, IGFBP2, IGFBP3 <br /><br>-Leptin<br /><br>-Urea <br /><br>Metabolomics: <br /><br>-Amino acid profile <br /><br>-Polar lipids<br /><br>Anthropometric measurements:<br /><br>-Head circumference <br /><br>-Length <br /><br>-Waist circumference<br /><br>-Mid-arm circumference <br>