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

This study is currently recruiting participants.
Verified June 2012 by Lactalis
Sponsor:
Information provided by (Responsible Party):
Lactalis
ClinicalTrials.gov Identifier:
NCT01611649
First received: May 25, 2012
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Infant Development
 Dietary Supplement: Formula containing dairy lipids and plant oils
Dietary Supplement: Formula containing plant oils
Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lactalis:

Primary Outcome Measures:
  • Sum of omega-3 fatty acid levels in membrane phospholipids of RBC [ Time Frame: after 4 months of consumption ] [ Designated as safety issue: No ]
    alpha linolenic acid (ALA) + eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA)


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

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611649

Locations
Italy
Clinica Mangiagalli Recruiting
Milan, Italy
Contact: Paola Roggero, Professor         paola.roggero@unimi.it    
Principal Investigator: Fabio Mosca, Professor            
Sub-Investigator: Paola Roggero, Pr            
Sponsors and Collaborators
Lactalis
Investigators
Principal Investigator: Fabio Mosca, Prof. Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
Study Director: Pascale le Ruyet, Dr. Lactalis
  More Information

No publications provided by Lactalis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lactalis
ClinicalTrials.gov Identifier: NCT01611649     History of Changes
Other Study ID Numbers: LRD-2012-REBECA
Study First Received: May 25, 2012
Last Updated: June 1, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Lactalis:
infant formula
dairy lipids
omega-3

ClinicalTrials.gov processed this record on May 23, 2013