Clinical trial NCT02332967: Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
Official title: Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Newborn Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 488
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stool consistency
timeFrame: 4 months
measure: Baby weight gain
timeFrame: 4 months
Secondary outcomes:
measure: Baby length and head circumference
timeFrame: 4 months
measure: Digestive tolerance using a questionnaire filled in by the mothers
timeFrame: 4 months
measure: Gut microbiota using microbiology method
timeFrame: 4 months
measure: Fat quantity in the stools
timeFrame: 4 months
measure: Baby body composition (DEXA)
timeFrame: 4 months
measure: Food intake by the baby
timeFrame: 4 months
measure: Rate of spitting up
timeFrame: 4 months
measure: Number of adverse events
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Gatroenterology and Nutrition, Pediatric dept, CHRU Lille
name: Dominique Turck, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beghin L, Marchandise X, Lien E, Bricout M, Bernet JP, Lienhardt JF, Jeannerot F, Menet V, Requillart JC, Marx J, De Groot N, Jaeger J, Steenhout P, Turck D. Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial. Clin Nutr. 2019 Jun;38(3):1023-1030. doi: 10.1016/j.clnu.2018.05.015. Epub 2018 Jun 1.