Groei, overgewicht en obesitas Growth and overweight
Conditions
Interventions
The intervention group (group A) will receive an infant formula with an
optimized amino acid composition and reduced protein content (test product) and
the control group (group B) will receive infan
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - Healthy term infants - Age
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant weight gain from inclusion to the age of 17 weeks. Amendment follow-up study: BMI at the age of 6 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Body composition - Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2, IGFBP3, leptin, amino acid profile, urea, metabolomics. - Anthropometric measurements: length, waist circumference, head circumference, mid-arm circumference. - Composition of fecal microbiota. Amendment follow-up study: - Body composition - Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2, IGFBP3, leptin, amino acid profile, urea, metabolomics. - Anthropometric measurements: weight, length, waist circumference, head circumference, mid-arm circumference. - Composition of fecal microbiota. - Blood pressure | — |
Countries
Netherlands
Outcome results
None listed