ProtEUs: Effects of an infant formula with an optimized amino acid composition on growth and body composition in infants

Completed

Conditions: Groei, overgewicht en obesitas
Growth and overweight

Registration Number: NL-OMON41548

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 146

Inclusion Criteria

- Healthy term infants
- Age <= 45 days after birth

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
- Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator*s clinical judgement
- Infants who need to be fed with a special diet other than a standard cow*s milk-based infant formula
- Infants with any history of or current participation in any other study involving investigational or marketed products.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Infant weight gain from inclusion to the age of 17 weeks.<br /><br><br /><br>Amendment follow-up study: BMI at the age of 6 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Body composition<br /><br>- Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2,<br /><br>IGFBP3, leptin, amino acid profile, urea, metabolomics.<br /><br>- Anthropometric measurements: length, waist circumference, head circumference,<br /><br>mid-arm circumference.<br /><br>- Composition of fecal microbiota.<br /><br><br /><br>Amendment follow-up study:<br /><br>- Body composition<br /><br>- Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2,<br /><br>IGFBP3, leptin, amino acid profile, urea, metabolomics.<br /><br>- Anthropometric measurements: weight, length, waist circumference, head<br /><br>circumference, mid-arm circumference.<br /><br>- Composition of fecal microbiota.<br /><br>- Blood pressure</p><br>