Effect of Formula on Growth of Infants From Overweight or Obese Mothers
NCT ID: NCT00820833
Last Updated: 2015-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2007-10-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1
Standard infant formula
standard infant formula
standard infant formula given from 3 to 12 months of age, as per standard requirement
2
Test formula
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.
3
Breastfeeding reference group
No interventions assigned to this group
Interventions
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standard infant formula
standard infant formula given from 3 to 12 months of age, as per standard requirement
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* newborn whose mother has diabetes
* newborn whose mother has a drug dependence during pregnancy
* newborn currently participating in another trial
3 Months
12 Months
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Jaime Inostroza, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de La Frontera
Locations
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Departamento de Medicina Interna, University de la Frontera
Temuco, , Chile
Countries
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References
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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.
Other Identifiers
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05.29.INF
Identifier Type: -
Identifier Source: org_study_id
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