'Study on infant Adiposity development To Understand the Role of early life Nutrition - the Sophia Saturn Study'
- Conditions
- ObesityOverweight1001842410003018
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 234
- 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 < 3 after 5 minutes) and no serious disease such as long-term artificial
ventilation and oxygen supply, broncho pulmonary dysplasia or other lung disease
- Written informed consent from both parents
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is change in fat mass index from 6 to 12 months of<br /><br>age. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary, associations with other body composition parameters (fat mass, lean<br /><br>mass, fat mass percentage, subcutaneous and visceral fat mass), anthropometric<br /><br>measurements (e.g. weight, length, weight-for-length, BMI and skinfolds SD),<br /><br>metabolic biomarkers (e.g. serum lipids, satiety hormones), eating behavior and<br /><br>neurocognitive development will be investigated. </p><br>