Effect of a Mix of Dairy Lipids and Plant Oils in Infant Formula on Omega-3 Fatty Acid in Red Blood Cells

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infant Development

Intervention / Treatment
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* Dietary Supplement: Formula containing dairy lipids and plant oils
* Dietary Supplement: Formula containing plant oils
* Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dairy lipids and plant oils<br> | Dietary Supplement: Formula containing dairy lipids and plant oils<br>* 4 months consumption<br>|
| Experimental: Plant oils<br> | Dietary Supplement: Formula containing plant oils<br>* 4 months consumption<br>|
| Experimental: Dairy lipids and plant oils, DHA+ARA<br>DHA: docosahexaenoic acid, ARA: arachidonic acid | Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA<br>* 4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils<br>|
| No Intervention: Human milk<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, dairy lipids, omega-3