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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611649
First Posted: June 5, 2012
Last Update Posted: April 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lactalis
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
  • Insulin-like Growth Factor 1 (IGF1) blood levels [ Time Frame: 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 ]
  • 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 ]
  • Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass [ Time Frame: during the 4 months consumption period ]
  • Total fatty acid levels in membrane phospholipids of RBC [ Time Frame: after 4 months of consumption ]
  • Evolution of blood total fatty acids levels between 0 and 4 months [ Time Frame: between 0 and 4 months ]

Enrollment: 117
Study Start Date: March 2012
Primary Completion Date: September 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611649


Locations
Italy
Clinica Mangiagalli
Milan, Italy
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

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
First Submitted: May 25, 2012
First Posted: June 5, 2012
Last Update Posted: April 21, 2015
Last Verified: April 2015

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