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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Lactalis.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014