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

Infant Nutrition Clinical Trial

Official title:

Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820833
• Other study ID #: 05.29.INF
• Status: Completed
• Phase: N/A
• First received: January 8, 2009
• Last updated: March 25, 2015
• Start date: October 2007
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2014
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 12 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

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

Locations

Country	Name	City	State
Chile	Departamento de Medicina Interna, University de la Frontera	Temuco

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean weight gain		3 months	Yes
Secondary	blood test assessments; body composition, bone density		9 months	Yes