Profilo Degli Acidi Grassi Omega-3 Dei Globuli Rossi in Neonati Sani Alimentati Con Una Formula Per l'Infanzia Contenente Una Miscela di Grassi Del Latte e Oli Vegetali
| Registry | NCT01611649, acronym REBECA |
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| Status | Completed |
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| Phase | Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, supportive care |
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| Enrollment | 117 (Actual) |
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| Sponsor | Lactalis (Industry) |
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| Conditions | Infant Development |
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| Interventions | Formula containing dairy lipids and plant oils, Formula containing plant oils, Formula containing dairy lipids and plant oils, DHA+ARA (Dietary supplement) |
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| Dates | start 2012-03-01, primary completion 2013-09-01, first posted 2012-06-05, last updated 2015-04-21 |
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| Locations | 1 site in Italy |
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Related Papers Related Patents Related Grants Related Experts
All trials for Infant Development All trials of Formula containing dairy lipids and plant oils All trials of Formula containing plant oils
-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Dairy lipids and plant oils | Experimental | Dietary Supplement: Formula containing dairy lipids and plant oils | |
| Plant oils | Experimental | Dietary Supplement: Formula containing plant oils | |
| Dairy lipids and plant oils, DHA+ARA | Experimental | Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA | DHA: docosahexaenoic acid, ARA: arachidonic acid |
| Human milk | No intervention | | |
- Formula containing dairy lipids and plant oils (Dietary supplement): 4 months consumption
- 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
+Outcome measures
Primary outcomes
- Sum of omega-3 fatty acid levels in membrane phospholipids of RBC [after 4 months of consumption]: alpha linolenic acid (ALA) + eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA)
Secondary outcomes
- 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) [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]
+Eligibility
Sex: All, ages: any to 21 Days, accepts healthy volunteers
Inclusion Criteria:
* Full term healthy newborn from normal pregnancy
* Newborn whose mother decided to not breastfeed or to stop breastfeed before the third week of life
Exclusion Criteria:
* Newborn with low-birth-weight (<2500 g)
* Newborn whose parents have planned a move within 6 months after birth
* Family history of allergy to milk protein
+Locations (1)
| Facility | City | Country | Status |
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| Clinica Mangiagalli | Milan | Italy | |
+Publications
- Results publication: 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. PMID 29433457
- Results publication: 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. PMID 29357820
- Results publication: 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. PMID 23072617
+Investigators