Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
- Conditions
- Healthy Newborn Infants
- Interventions
- Other: Whey predominant starter formulaOther: Whey predominant starter formula + 40% palmitic acidOther: Whey predominant starter formula + 50% palmitic acid
- Registration Number
- NCT02332967
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.
- Detailed Description
Human milk is considered as the golden standard for infant formula. In human milk and infant formula lipids provide about 55% of energy for the infant and represent as such a major nutrient for the baby. The vast majority of the lipids in human milk is composed of triacylglycerols (98% of total lipids) and the remainder percent are phospholipids. Triglycerides are composed of the glycerol backbone to which three fatty acids are bound. In human milk, palmitate (16:0) is the major long chain saturated fatty acid representing 22% to 26% of total fatty acids, esterified to approximately 70% in sn-2 position on the glycerol backbone. Unsaturated fatty acids such as oleic acid (18:1) and linoleic acid (18:2n-6) are preferentially esterified at the 1 and 3 position. In infant formulas the major source of palmitic acid is palm oil or palm olein where palmitate is, however, preferentially in the external 1,3 positions, and mono- and polyunsaturated fatty acids are usually esterified at the 2-position of the triacylgycerol.
The aim of this study is to assess the safety and efficacy of infant formula containing 40% and 50%, respectively, of palmitic acid in sn-2 position.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 488
- healthy newborn infants
- full term infant (37 - 42 weeks gestation)
- birth weight between 2.5 and 4.5 kg
- singleton birth
- the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
- having obtained his7her legal representative's informed consent
- congenital illness or malformation that may affect normal growth
- significant pre-natal and/or post-natal disease
- hospitalization in the first 14 days of life after the child has left the maternity ward
- receiving antibiotic treatment at time of enrolment
- newborn whose parents/caregivers cannot be expected to comply with treatment
- newborn currently participating in another interventional clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whey predominant starter formula + 40% palmitic acid Whey predominant starter formula Whey predominant starter formula + 40% palmitic acid in sn-2 position Whey predominant starter formula Whey predominant starter formula + 50% palmitic acid Whey predominant starter formula Whey predominant starter formula Whey predominant starter formula + 40% palmitic acid Whey predominant starter formula Whey predominant starter formula + 50% palmitic acid Whey predominant starter formula Whey predominant starter formula + 50% palmitic acid in sn-2 position
- Primary Outcome Measures
Name Time Method Baby weight gain 4 months To demonstrate that the weight gain in babies receiving the experimental formula is the same as with the control formula
Stool consistency 4 months To demonstrate that the infants receiving an infant formula with 40% or 50% of palmitic acid during the first 4 months of life have softer stools than the ones receiving the control formula.
- Secondary Outcome Measures
Name Time Method Number of adverse events 4 months To evaluate the frequency of episodes of morbidity (adverse events)
Digestive tolerance using a questionnaire filled in by the mothers 4 months To assess the infants' digestive tolerance of the starter formula
Baby body composition (DEXA) 4 months To compare body composition
Food intake by the baby 4 months To compare volume intake between the groups
Fat quantity in the stools 4 months To assess fat absorption
Rate of spitting up 4 months To compare spitting up between the groups
Baby length and head circumference 4 months To assess whether the groups have comparable changes in length, and head circumference
Gut microbiota using microbiology method 4 months To compare gut microbiota between the groups