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Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.
The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Modified formula |
|
| 2 | No Intervention | Standard formula | |
| 3 | No Intervention | Breastfed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified formula (MFGM-enriched formula with reduced energy and protein content) | Dietary Supplement | MFGM-enriched formula with reduced energy and protein content |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Pletysmography (% body fat) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological development | Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological development | Wechsler Intelligence Scale for Children, 4th Ed (higher score - better outcome) | 6.5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of clinical sciences, pediatrics, Umeå University | Umeå | SE-90185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25714582 | Derived | Timby N, Hernell O, Vaarala O, Melin M, Lonnerdal B, Domellof M. Infections in infants fed formula supplemented with bovine milk fat globule membranes. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):384-9. doi: 10.1097/MPG.0000000000000624. | |
| 24500150 | Derived | Timby N, Domellof E, Hernell O, Lonnerdal B, Domellof M. Neurodevelopment, nutrition, and growth until 12 mo of age in infants fed a low-energy, low-protein formula supplemented with bovine milk fat globule membranes: a randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):860-8. doi: 10.3945/ajcn.113.064295. Epub 2014 Feb 5. |
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