Obesity Overweight
Conditions
Interventions
Intervention: Nuturis formula feeding, start within 6 weeks after birth until 6
months of age
Control: Standard formula feeding, start within 6 weeks after birth until 6
months of age
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: - Participation in the Sophia Pluto Study (MEC-2012-164) - Parents have decided to start formula feeding - Healthy, full-term infants (gestational age >= 37 weeks) - Children with a neonatal period without severe asphyxia (defined as an Apgar score
Exclusion criteria
Exclusion criteria: - Maternal use of corticosteroids during pregnancy - Pregnant women/parents known to have other significant medical condition (including during pregnancy) that might interfere with the study or know to affect intra-uterine growth as per investigator's clinical judgement - Incapability of the parents to comply with the study protocol - Confirmed intra-uterine infection - Infants with chromosomal disorders, known syndromes and serious dismorphic symptoms suggestive for a (yet unknown) syndrome - Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism or inborn errors of metabolism - Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study, such as certain medication (e.g. cortical steroids) or major surgery, as per investigator's clinical judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is change in fat mass index from 6 to 12 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary, associations with other body composition parameters (fat mass, lean mass, fat mass percentage, subcutaneous and visceral fat mass), anthropometric measurements (e.g. weight, length, weight-for-length, BMI and skinfolds SD), metabolic biomarkers (e.g. serum lipids, satiety hormones), eating behavior and neurocognitive development will be investigated. | — |
Countries
Netherlands
Outcome results
None listed