Effect of Formula on Growth of Infants From Overweight or Obese Mothers

N/ACompletedNCT00820833

Société des Produits Nestlé (SPN)230 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

230

Conditions

Infant Nutrition

Interventions

standard infant formulaOTHER

standard infant formula given from 3 to 12 months of age, as per standard requirement

Test formulaOTHER

Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Departamento de Medicina Interna, University de la Frontera

Temuco, Chile

Outcomes

Primary Outcomes

mean weight gain

Time frame: 3 months

Secondary Outcomes

blood test assessments; body composition, bone density

Time frame: 9 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.