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 oils; Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA; Dietary 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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-25
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-05
• Primary Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

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