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
1 other identifier
interventional
230
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 26, 2015
December 1, 2014
2.7 years
January 8, 2009
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean weight gain
3 months
Secondary Outcomes (1)
blood test assessments; body composition, bone density
9 months
Study Arms (3)
1
PLACEBO COMPARATORStandard infant formula
2
EXPERIMENTALTest formula
3
NO INTERVENTIONBreastfeeding reference group
Interventions
standard infant formula given from 3 to 12 months of age, as per standard requirement
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departamento de Medicina Interna, University de la Frontera
Temuco, Chile
Related Publications (1)
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.
PMID: 24637965DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Inostroza, PhD
Universidad de La Frontera
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 12, 2009
Study Start
October 1, 2007
Primary Completion
June 1, 2010
Study Completion
December 1, 2014
Last Updated
March 26, 2015
Record last verified: 2014-12