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

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.
 
ClinicalTrials.gov Identifier: NCT00820833
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
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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

Condition or disease Intervention/treatment Phase
Infant Nutrition Other: standard infant formula Other: Test formula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. mean weight gain [ Time Frame: 3 months ]

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

Eligibility Criteria
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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
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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
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Chile
Departamento de Medicina Interna, University de la Frontera
Temuco, Chile
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Jaime Inostroza, PhD Universidad de la Frontera
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00820833    
Other Study ID Numbers: 05.29.INF
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: December 2014
Keywords provided by Nestlé:
infant formula
obesity
growth
Additional relevant MeSH terms:
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Overweight
Body Weight