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The objective of this study is to determine whether the use of a mix of dairy lipids and plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula containing only lipids of plant origin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dairy lipids and plant oils | Experimental |
| |
| Plant oils | Experimental |
| |
| Dairy lipids and plant oils, DHA+ARA | Experimental | DHA: docosahexaenoic acid, ARA: arachidonic acid |
|
| Human milk | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula containing dairy lipids and plant oils | Dietary Supplement | 4 months consumption |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of omega-3 fatty acid levels in membrane phospholipids of RBC | alpha linolenic acid (ALA) + eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA) | after 4 months of consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Serum total fatty acid levels | after 4 months of consumption | |
| Insulin-like Growth Factor 1 (IGF1) blood levels | after 4 months of consumption | |
| Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Mosca, Prof. | Fondazione IRCCS CÃ Grande Ospedale Maggiore Policlinico | Principal Investigator |
| Pascale le Ruyet, Dr. | Lactalis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Mangiagalli | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29433457 | Derived | Gianni ML, Roggero P, Baudry C, Fressange-Mazda C, Galli C, Agostoni C, le Ruyet P, Mosca F. An infant formula containing dairy lipids increased red blood cell membrane Omega 3 fatty acids in 4 month-old healthy newborns: a randomized controlled trial. BMC Pediatr. 2018 Feb 13;18(1):53. doi: 10.1186/s12887-018-1047-5. | |
| 29357820 |
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| Formula containing plant oils | Dietary Supplement | 4 months consumption |
|
| Formula containing dairy lipids and plant oils, DHA+ARA | Dietary Supplement | 4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils |
|
| after 4 months of consumption |
| Amount of formula consumed, occurrence of spit-up and vomit, description of the number, color and consistency of infant stools as a measure of tolerance to the formula | during the 4 months consumption period |
| Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass | during the 4 months consumption period |
| Total fatty acid levels in membrane phospholipids of RBC | after 4 months of consumption |
| Evolution of blood total fatty acids levels between 0 and 4 months | between 0 and 4 months |
| Gianni ML, Roggero P, Baudry C, Fressange-Mazda C, le Ruyet P, Mosca F. No effect of adding dairy lipids or long chain polyunsaturated fatty acids on formula tolerance and growth in full term infants: a randomized controlled trial. BMC Pediatr. 2018 Jan 22;18(1):10. doi: 10.1186/s12887-018-0985-2. |
| 23072617 | Derived | Gianni ML, Roggero P, Baudry C, Ligneul A, Morniroli D, Garbarino F, le Ruyet P, Mosca F. The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial. BMC Pediatr. 2012 Oct 17;12:164. doi: 10.1186/1471-2431-12-164. |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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