Infant Development
Conditions
Keywords
infant formula, dairy lipids, omega-3
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.
Interventions
DIETARY_SUPPLEMENTFormula containing dairy lipids and plant oils
4 months consumption
DIETARY_SUPPLEMENTFormula containing plant oils
4 months consumption
DIETARY_SUPPLEMENTFormula containing dairy lipids and plant oils, DHA+ARA
4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils
Sponsors
Lactalis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Serum total fatty acid levels | after 4 months of consumption |
| 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 |
| Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass | during the 4 months consumption period |
Countries
Italy
Outcome results
None listed