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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00820833
First Posted: January 12, 2009
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

Enrollment: 230
Study Start Date: October 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00820833     History of Changes
Other Study ID Numbers: 05.29.INF
First Submitted: January 8, 2009
First Posted: January 12, 2009
Last Update Posted: March 26, 2015
Last Verified: December 2014

Keywords provided by Nestlé:
infant formula
obesity
growth

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms