Clinical trial NCT01611649: Effect of a Mix of Dairy Lipids and Plant Oils in Infant Formula on Omega-3 Fatty Acid in Red Blood Cells
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant Development
Keywords: infant formula
dairy lipids
omega-3
Lead sponsor: Lactalis
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 117
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Sum of omega-3 fatty acid levels in membrane phospholipids of RBC
timeFrame: after 4 months of consumption
Secondary outcomes:
measure: Serum total fatty acid levels
timeFrame: after 4 months of consumption
measure: Insulin-like Growth Factor 1 (IGF1) blood levels
timeFrame: after 4 months of consumption
measure: Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)
timeFrame: after 4 months of consumption
measure: 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
timeFrame: during the 4 months consumption period
measure: Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass
timeFrame: during the 4 months consumption period
measure: Total fatty acid levels in membrane phospholipids of RBC
timeFrame: after 4 months of consumption
measure: Evolution of blood total fatty acids levels between 0 and 4 months
timeFrame: between 0 and 4 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Clinica Mangiagalli
Study officials:
affiliation: Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico
name: Fabio Mosca, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lactalis
name: Pascale le Ruyet, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.