An interventional study of Whey predominant starter formula and Whey predominant starter formula + 40% palmitic acid in Healthy Newborn Infants, sponsored by Société des Produits Nestlé (SPN). Completed. Open to participants aged 1 Week to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-13.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment
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.
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.
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Whey predominant starter formula
Other: Whey predominant starter formula + 40% palmitic acid · Other: Whey predominant starter formula + 50% palmitic acid
Whey predominant starter formula + 40% palmitic acid in sn-2 position
Other: Whey predominant starter formula
Whey predominant starter formula + 50% palmitic acid in sn-2 position
Other: Whey predominant starter formula
Milk powder product given to babies between 1 week and 4 months
Milk powder product containing 40% of palmitic acid
Milk powder product containing 50% of palmitic acid
Stool consistency
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.
Time frame: 4 months
Baby weight gain
To demonstrate that the weight gain in babies receiving the experimental formula is the same as with the control formula
Time frame: 4 months
Baby length and head circumference
To assess whether the groups have comparable changes in length, and head circumference
Time frame: 4 months
Digestive tolerance using a questionnaire filled in by the mothers
To assess the infants' digestive tolerance of the starter formula
Time frame: 4 months
Gut microbiota using microbiology method
To compare gut microbiota between the groups
Time frame: 4 months
Fat quantity in the stools
To assess fat absorption
Time frame: 4 months
Baby body composition (DEXA)
To compare body composition
Time frame: 4 months
Food intake by the baby
To compare volume intake between the groups
Time frame: 4 months
Rate of spitting up
To compare spitting up between the groups
Time frame: 4 months
Number of adverse events
To evaluate the frequency of episodes of morbidity (adverse events)
Time frame: 4 months
No study locations are listed for this record.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)