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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00820833
First received: January 8, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Infant Nutrition
Other: standard infant formula
Other: Test formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • mean weight gain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • blood test assessments; body composition, bone density [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: October 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Standard infant formula
Other: standard infant formula
standard infant formula given from 3 to 12 months of age, as per standard requirement
Experimental: 2
Test formula
Other: 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.
No Intervention: 3
Breastfeeding reference group

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820833

Locations
Chile
Departamento de Medicina Interna, University de la Frontera
Temuco, Chile
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Jaime Inostroza, PhD Universidad de la Frontera
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00820833     History of Changes
Other Study ID Numbers: 05.29.INF
Study First Received: January 8, 2009
Last Updated: March 12, 2014
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Nestlé:
infant formula
obesity
growth

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014