Healthy Newborn Infants
Conditions
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.
Interventions
OTHERWhey predominant starter formula
Milk powder product given to babies between 1 week and 4 months
OTHERWhey predominant starter formula + 40% palmitic acid
Milk powder product containing 40% of palmitic acid
OTHERWhey predominant starter formula + 50% palmitic acid
Milk powder product containing 50% of palmitic acid
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota using microbiology method | 4 months | To compare gut microbiota between the groups |
| Fat quantity in the stools | 4 months | To assess fat absorption |
| Baby body composition (DEXA) | 4 months | To compare body composition |
| Baby length and head circumference | 4 months | To assess whether the groups have comparable changes in length, and head circumference |
| Rate of spitting up | 4 months | To compare spitting up between the groups |
| Number of adverse events | 4 months | To evaluate the frequency of episodes of morbidity (adverse events) |
| Food intake by the baby | 4 months | To compare volume intake between the groups |
| Digestive tolerance using a questionnaire filled in by the mothers | 4 months | To assess the infants' digestive tolerance of the starter formula |
Outcome results
None listed