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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
117
4 months consumption
4 months consumption
4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils
Clinica Mangiagalli
Milan, Italy
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)
Time frame: after 4 months of consumption
Serum total fatty acid levels
Time frame: after 4 months of consumption
Insulin-like Growth Factor 1 (IGF1) blood levels
Time frame: after 4 months of consumption
Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)
Time frame: 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
Time frame: during the 4 months consumption period
Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass
Time frame: during the 4 months consumption period
Total fatty acid levels in membrane phospholipids of RBC
Time frame: after 4 months of consumption
Evolution of blood total fatty acids levels between 0 and 4 months
Time frame: between 0 and 4 months
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