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| Name | Class |
|---|---|
| Arla Foods | INDUSTRY |
| Children's Hospital of Fudan University | OTHER |
| University of California, Davis | OTHER |
| University of Illinois at Urbana-Champaign |
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The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.
Breast-fed infants will be used as a reference group and formula-fed infants will be fed control formula or the same formula supplemented with Osteopontin at a concentration 50% or 100% of that of breast milk. The hypothesis is that supplementation of bovine milk Osteopontin in infant formula will have positive effects on infant growth, health and immune functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference group | No Intervention | Human milk breastfeeding | |
| Control formula | Active Comparator | Standard infant formula, with no Osteopontin supplemented. |
|
| Formula with 50% Osteopontin | Active Comparator | Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk. |
|
| Formula with 100% Osteopontin | Active Comparator | Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula supplemented with bovine milk Osteopontin | Other | Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions. | 1, 4, and 6 postnatal months |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric parameters: body length, body weight, and head circumferences at each visit. | 1, 2, 3, 4, 5, and 6 postnatal months | |
| Dietary, stool consistency and well being recorded by 3 day questionnaires | 1, 2, 3, 4, 5, and 6 postnatal months |
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Mothers Inclusion Criteria:
Infants Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongmei Peng, M.D. | Children's Hospital of Fudan University | Principal Investigator |
| Bo Lonnerdal, Ph.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10657301 | Background | Ashkar S, Weber GF, Panoutsakopoulou V, Sanchirico ME, Jansson M, Zawaideh S, Rittling SR, Denhardt DT, Glimcher MJ, Cantor H. Eta-1 (osteopontin): an early component of type-1 (cell-mediated) immunity. Science. 2000 Feb 4;287(5454):860-4. doi: 10.1126/science.287.5454.860. | |
| 15373904 | Background | Nagatomo T, Ohga S, Takada H, Nomura A, Hikino S, Imura M, Ohshima K, Hara T. Microarray analysis of human milk cells: persistent high expression of osteopontin during the lactation period. Clin Exp Immunol. 2004 Oct;138(1):47-53. doi: 10.1111/j.1365-2249.2004.02549.x. |
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| OTHER |
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| Standard infant formula | Other | Infant formula without supplementation of bovine milk Osteopontin |
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| Adverse events and concomitant medications recorded by heath forms as a measure of safety and tolerability. | 1, 2, 3, 4, 5, and 6 postnatal months |
| 15731245 | Background | Rollo EE, Hempson SJ, Bansal A, Tsao E, Habib I, Rittling SR, Denhardt DT, Mackow ER, Shaw RD. The cytokine osteopontin modulates the severity of rotavirus diarrhea. J Virol. 2005 Mar;79(6):3509-16. doi: 10.1128/JVI.79.6.3509-3516.2005. |
| 26465791 | Derived | Lonnerdal B, Kvistgaard AS, Peerson JM, Donovan SM, Peng YM. Growth, Nutrition, and Cytokine Response of Breast-fed Infants and Infants Fed Formula With Added Bovine Osteopontin. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):650-7. doi: 10.1097/MPG.0000000000001005. |