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

Infant Development Clinical Trial

— REBECA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611649
• Other study ID #: LRD-2012-REBECA
• Status: Completed
• Phase: Phase 2
• First received: May 25, 2012
• Last updated: April 20, 2015
• Start date: March 2012

Study information

• Verified date: April 2015
• Source: Lactalis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infant Development

Intervention

Dietary Supplement:
• Formula containing dairy lipids and plant oils
4 months consumption
• Formula containing plant oils
4 months consumption
• Formula containing dairy lipids and plant oils, DHA+ARA
4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils

Locations

Country	Name	City	State
Italy	Clinica Mangiagalli	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Lactalis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum total fatty acid levels		after 4 months of consumption	No
Secondary	Insulin-like Growth Factor 1 (IGF1) blood levels		after 4 months of consumption	No
Secondary	Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)		after 4 months of consumption	No
Secondary	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	No
Secondary	Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass		during the 4 months consumption period	No
Secondary	Total fatty acid levels in membrane phospholipids of RBC		after 4 months of consumption	No
Secondary	Evolution of blood total fatty acids levels between 0 and 4 months		between 0 and 4 months	No