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CompletedNCT01611649REBECAUpdated Apr 21, 2015

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

A Phase 2 interventional study of Formula containing dairy lipids and plant oils and Formula containing plant oils in Infant Development, sponsored by Lactalis. Completed at 1 site in Italy. Open to participants aged Up to 21 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-21.

Sponsored by Lactalis · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
Up to 21 Days
Sex
All
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Study 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.

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Conditions studied

  • Infant Development

Keywords

  • infant formula
  • dairy lipids
  • omega-3
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In context

Lead sponsor

Lactalis is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 21 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
117 participants (actual)

Study arms

  • Experimental
    Dairy lipids and plant oils

    Dietary Supplement: Formula containing dairy lipids and plant oils

  • Experimental
    Plant oils

    Dietary Supplement: Formula containing plant oils

  • 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

  • No intervention
    Human milk

Interventions

  • Dietary supplementFormula containing dairy lipids and plant oils

    4 months consumption

  • Dietary supplementFormula containing plant oils

    4 months consumption

  • Dietary supplementFormula containing dairy lipids and plant oils, DHA+ARA

    4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: after 4 months of consumption

Secondary outcomes

  1. Serum total fatty acid levels

    Time frame: after 4 months of consumption

  2. Insulin-like Growth Factor 1 (IGF1) blood levels

    Time frame: after 4 months of consumption

  3. Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)

    Time frame: after 4 months of consumption

  4. 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

  5. Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass

    Time frame: during the 4 months consumption period

  6. Total fatty acid levels in membrane phospholipids of RBC

    Time frame: after 4 months of consumption

  7. Evolution of blood total fatty acids levels between 0 and 4 months

    Time frame: between 0 and 4 months

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Study locations

1 site
  • Clinica Mangiagalli
    Milan, Italy
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References and documents

Publications

  • Gianni ML, Roggero P, Baudry C, Fressange-Mazda C, Galli C, Agostoni C, le Ruyet P, Mosca F. An infant formula containing dairy lipids increased red blood cell membrane Omega 3 fatty acids in 4 month-old healthy newborns: a randomized controlled trial. BMC Pediatr. 2018 Feb 13;18(1):53. doi: 10.1186/s12887-018-1047-5. PubMed 29433457 ↗
  • Gianni ML, Roggero P, Baudry C, Fressange-Mazda C, le Ruyet P, Mosca F. No effect of adding dairy lipids or long chain polyunsaturated fatty acids on formula tolerance and growth in full term infants: a randomized controlled trial. BMC Pediatr. 2018 Jan 22;18(1):10. doi: 10.1186/s12887-018-0985-2. PubMed 29357820 ↗
  • Gianni ML, Roggero P, Baudry C, Ligneul A, Morniroli D, Garbarino F, le Ruyet P, Mosca F. The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial. BMC Pediatr. 2012 Oct 17;12:164. doi: 10.1186/1471-2431-12-164. PubMed 23072617 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01611649
Lead sponsor
Lactalis
Responsible party
Sponsor
First posted
Jun 5, 2012
Start date
Mar 2012
Primary completion
Sep 2013
Last update
Apr 21, 2015

Study contacts

Fabio Mosca, Prof.
principal investigator · Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
Pascale le Ruyet, Dr.
study director · Lactalis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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