Effect of Formula on Growth of Infants From Overweight or Obese Mothers
Not Applicable
Completed
- Conditions
- Infant Nutrition
- Registration Number
- NCT00820833
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method mean weight gain 3 months
- Secondary Outcome Measures
Name Time Method blood test assessments; body composition, bone density 9 months
Trial Locations
- Locations (1)
Departamento de Medicina Interna, University de la Frontera
🇨🇱Temuco, Chile
Departamento de Medicina Interna, University de la Frontera🇨🇱Temuco, Chile