Effect of a Mix of Dairy Lipids and Plant Oils in Infant Formula on Omega-3 Fatty Acid in Red Blood Cells
Phase 2
Completed
- Conditions
- Infant Development
- Interventions
- Dietary Supplement: Formula containing dairy lipids and plant oilsDietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARADietary Supplement: Formula containing plant oils
- Registration Number
- NCT01611649
- Lead Sponsor
- Lactalis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dairy lipids and plant oils Formula containing dairy lipids and plant oils - Dairy lipids and plant oils, DHA+ARA Formula containing dairy lipids and plant oils, DHA+ARA DHA: docosahexaenoic acid, ARA: arachidonic acid Plant oils Formula containing plant oils -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Clinica Mangiagalli
🇮🇹Milan, Italy