Effect of Formula on Growth of Infants From Overweight or Obese Mothers
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ClinicalTrials.gov Identifier: NCT00820833 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : March 26, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infant Nutrition | Other: standard infant formula Other: Test formula | Not Applicable |
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 |

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
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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
|
- mean weight gain [ Time Frame: 3 months ]
- blood test assessments; body composition, bone density [ Time Frame: 9 months ]

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Ages Eligible for Study: | 3 Months to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Chile | |
Departamento de Medicina Interna, University de la Frontera | |
Temuco, Chile |
Principal Investigator: | Jaime Inostroza, PhD | Universidad de la Frontera |
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 |
infant formula obesity growth |
Overweight Body Weight |