Infant Nutrition
Conditions
Keywords
infant formula, obesity, growth
Brief summary
The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth
Interventions
standard infant formula given from 3 to 12 months of age, as per standard requirement
OTHERTest formula
Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* healthy newborn infant * birth weight between 2500g and 4800g * singleton birth * mother's BMI before pregnancy was between 26 and 25 * for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age * for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age * having obtained signed informed consent of legal representative
Exclusion criteria
* body weight smaller than 5th percentile for that gestational age * newborn whose mother has diabetes * newborn whose mother has a drug dependence during pregnancy * newborn currently participating in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean weight gain | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| blood test assessments; body composition, bone density | 9 months |
Countries
Chile
Outcome results
None listed