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

April 20, 2015 updated by: Lactalis

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Clinica Mangiagalli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dairy lipids and plant oils
Dietary supplement: Formula containing dairy lipids and plant oils
4 months consumption
Experimental: Plant oils
Dietary supplement: Formula containing plant oils
4 months consumption
Experimental: Dairy lipids and plant oils, DHA+ARA
DHA: docosahexaenoic acid, ARA: arachidonic acid
Dietary supplement: Formula containing dairy lipids and plant oils, DHA+ARA
4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils
No Intervention: Human milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sum of omega-3 fatty acid levels in membrane phospholipids of RBC
Time Frame: after 4 months of consumption
alpha linolenic acid (ALA) + eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA)
after 4 months of consumption

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum total fatty acid levels
Time Frame: after 4 months of consumption
after 4 months of consumption
Insulin-like Growth Factor 1 (IGF1) blood levels
Time Frame: after 4 months of consumption
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
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
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
during the 4 months consumption period
Total fatty acid levels in membrane phospholipids of RBC
Time Frame: after 4 months of consumption
after 4 months of consumption
Evolution of blood total fatty acids levels between 0 and 4 months
Time Frame: between 0 and 4 months
between 0 and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lactalis

Investigators

  • Principal Investigator: Fabio Mosca, Prof., Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
  • Study Director: Pascale le Ruyet, Dr., Lactalis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

June 1, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LRD-2012-REBECA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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