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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 8, 2009
Last updated: March 25, 2015
Last verified: December 2014

January 8, 2009
March 25, 2015
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
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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

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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
Inostroza J, Haschke F, Steenhout P, Grathwohl D, Nelson SE, Ziegler EE. Low-protein formula slows weight gain in infants of overweight mothers. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):70-7. doi: 10.1097/MPG.0000000000000349.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
3 Months to 12 Months
Contact information is only displayed when the study is recruiting subjects
Not Provided
Principal Investigator: Jaime Inostroza, PhD Universidad de la Frontera
December 2014

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