Infant DevelopmentPhase 2REBECANCT01611649
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 study testing Formula containing dairy lipids and plant oils, Formula containing plant oils and Formula containing dairy lipids and plant oils, DHA+ARA in people with Infant Development, run by Lactalis at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Formula containing dairy lipids and plant oils, Formula containing plant oils and Formula containing dairy lipids and plant oils, DHA+ARA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term healthy newborn from normal pregnancy
- Newborn whose mother decided to not breastfeed or to stop breastfeed before the third week of life
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Infant Development
- Being tested
- Formula containing dairy lipids and plant oils, Formula containing plant oils, Formula containing dairy lipids and plant oils, DHA+ARA
- Keywords
- infant formula, dairy lipids, omega-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula containing dairy lipids and plant oilsDietary supplement
4 months consumption
Formula containing plant oilsDietary supplement
4 months consumption
Formula containing dairy lipids and plant oils, DHA+ARADietary supplement
4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils
| Study group | Role | What they receive |
|---|---|---|
| Dairy lipids and plant oils | Experimental | Not described Receives: Dietary Supplement: Formula containing dairy lipids and plant oils |
| Plant oils | Experimental | Not described Receives: Dietary Supplement: Formula containing plant oils |
| Dairy lipids and plant oils, DHA+ARA | Experimental | DHA: docosahexaenoic acid, ARA: arachidonic acid Receives: Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA |
| Human milk | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: after 4 months of consumption
Secondary outcomes (7)
Serum total fatty acid levels
Measured: after 4 months of consumption
Insulin-like Growth Factor 1 (IGF1) blood levels
Measured: after 4 months of consumption
Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)
Measured: 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
Measured: during the 4 months consumption period
Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass
Measured: during the 4 months consumption period
Total fatty acid levels in membrane phospholipids of RBC
Measured: after 4 months of consumption
Evolution of blood total fatty acids levels between 0 and 4 months
Measured: between 0 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabio Mosca, Prof., Principal investigator, Fondazione IRCCS Cà Grande Ospedale Maggiore PoliclinicoPascale le Ruyet, Dr., Study director, Lactalis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611649
- Sponsor's protocol ID
- LRD-2012-REBECA
- Acronym
- REBECA
- Status last verified
- Apr 2015
- First submitted
- 25 May 2012
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 29433457Gianni 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 29357820Gianni 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01611649
- Acronym / sponsor ID
- REBECA / LRD-2012-REBECA
- Conditions
- Infant Development
- Keywords
- infant formula, dairy lipids, omega-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARADHA: docosahexaenoic acid, ARA: arachidonic acid |
| Human milk | No intervention | – |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Full term healthy newborn from normal pregnancy
- Newborn whose mother decided to not breastfeed or to stop breastfeed before the third week of life
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formula containing dairy lipids and plant oils4 months consumption | Dietary supplement | Dairy lipids and plant oils |
| Formula containing plant oils4 months consumption | Dietary supplement | Plant oils |
| Formula containing dairy lipids and plant oils, DHA+ARA4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils | Dietary supplement | Dairy lipids and plant oils, DHA+ARA |
Primary outcome
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)
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Derived from this study: PubMed 29433457Gianni 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.
- Derived from this study: PubMed 29357820Gianni 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.
- Derived from this study: PubMed 23072617Gianni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Mosca, Prof. principal investigator
Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
Pascale le Ruyet, Dr. study director
Lactalis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formula containing dairy lipids and plant oils, Formula containing plant oils and Formula containing dairy lipids and plant oils, DHA+ARA in people with Infant Development, run by Lactalis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of omega-3 fatty acid levels in membrane phospholipids of RBC (time frame: after 4 months of consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611649, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.