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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: February 19, 2013
Last verified: February 2013
History of Changes

January 8, 2009
February 19, 2013
October 2007
June 2010   (final data collection date for primary outcome measure)
mean weight gain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00820833 on ClinicalTrials.gov Archive Site
blood test assessments; body composition, bone density [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Formula on Growth of Infants From Overweight or Obese Mothers
Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Infant Nutrition
  • Other: standard infant formula
    standard infant formula given from 3 to 12 months of age, as per standard requirement
  • 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.
  • Placebo Comparator: 1
    Standard infant formula
    Intervention: Other: standard infant formula
  • Experimental: 2
    Test formula
    Intervention: Other: Test formula
  • No Intervention: 3
    Breastfeeding reference group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
December 2014
June 2010   (final data collection date for primary outcome measure)

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
Both
3 Months to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00820833
05.29.INF
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Jaime Inostroza, PhD Universidad de la Frontera
Nestlé
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP