Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

Conditions
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Healthy Newborn Infants

Intervention / Treatment
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* Other: Whey predominant starter formula
* Other: Whey predominant starter formula + 40% palmitic acid
* Other: Whey predominant starter formula + 50% palmitic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whey predominant starter formula<br>Whey predominant starter formula | Other: Whey predominant starter formula + 40% palmitic acid<br>* Milk powder product containing 40% of palmitic acid<br>Other: Whey predominant starter formula + 50% palmitic acid<br>* Milk powder product containing 50% of palmitic acid<br>|
| Experimental: Whey predominant starter formula + 40% palmitic acid<br>Whey predominant starter formula + 40% palmitic acid in sn-2 position | Other: Whey predominant starter formula<br>* Milk powder product given to babies between 1 week and 4 months<br>|
| Experimental: Whey predominant starter formula + 50% palmitic acid<br>Whey predominant starter formula + 50% palmitic acid in sn-2 position | Other: Whey predominant starter formula<br>* Milk powder product given to babies between 1 week and 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baby length and head circumference | To assess whether the groups have comparable changes in length, and head circumference | 4 months | 
| Digestive tolerance using a questionnaire filled in by the mothers | To assess the infants' digestive tolerance of the starter formula | 4 months | 
| Gut microbiota using microbiology method | To compare gut microbiota between the groups | 4 months | 
| Fat quantity in the stools | To assess fat absorption | 4 months | 
| Baby body composition (DEXA) | To compare body composition | 4 months | 
| Food intake by the baby | To compare volume intake between the groups | 4 months | 
| Rate of spitting up | To compare spitting up between the groups | 4 months | 
| Number of adverse events | To evaluate the frequency of episodes of morbidity (adverse events) | 4 months |