NCT01611649

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

May 25, 2012

Last Update Submit

April 20, 2015

Conditions

Infant Development

Keywords

infant formuladairy lipidsomega-3

Outcome Measures

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)

    after 4 months of consumption

Secondary Outcomes (7)

  • Serum total fatty acid levels

    after 4 months of consumption

  • Insulin-like Growth Factor 1 (IGF1) blood levels

    after 4 months of consumption

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

    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

    during the 4 months consumption period

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

    during the 4 months consumption period

  • +2 more secondary outcomes

Study Arms (4)

Dairy lipids and plant oils

EXPERIMENTAL
Dietary Supplement: Formula containing dairy lipids and plant oils

Plant oils

EXPERIMENTAL
Dietary Supplement: Formula containing plant oils

Dairy lipids and plant oils, DHA+ARA

EXPERIMENTAL

DHA: docosahexaenoic acid, ARA: arachidonic acid

Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA

Human milk

NO INTERVENTION

Interventions

Formula containing dairy lipids and plant oilsDIETARY_SUPPLEMENT

4 months consumption

Dairy lipids and plant oils
Formula containing plant oilsDIETARY_SUPPLEMENT

4 months consumption

Plant oils
Formula containing dairy lipids and plant oils, DHA+ARADIETARY_SUPPLEMENT

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

Dairy lipids and plant oils, DHA+ARA

Eligibility Criteria

AgeUp to 21 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full term healthy newborn from normal pregnancy
  • Newborn whose mother decided to not breastfeed or to stop breastfeed before the third week of life

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Mangiagalli

Milan, Italy

Location

Related Publications (3)

  • 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.

    PMID: 29433457DERIVED

  • 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.

    PMID: 29357820DERIVED

  • 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.

    PMID: 23072617DERIVED

MeSH Terms

Interventions

Plant Oils

Intervention Hierarchy (Ancestors)

OilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Fabio Mosca, Prof.

    Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

  • Pascale le Ruyet, Dr.

    Lactalis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 5, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2013

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

IT(1)