Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

NCT ID: NCT02332967

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-09-30

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.

Conditions

Healthy Newborn Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Whey predominant starter formula

Whey predominant starter formula

Group Type: ACTIVE_COMPARATOR

Whey predominant starter formula + 40% palmitic acid

Intervention Type: OTHER

Milk powder product containing 40% of palmitic acid

Whey predominant starter formula + 50% palmitic acid

Intervention Type: OTHER

Milk powder product containing 50% of palmitic acid

Whey predominant starter formula + 40% palmitic acid

Whey predominant starter formula + 40% palmitic acid in sn-2 position

Group Type: EXPERIMENTAL

Whey predominant starter formula

Intervention Type: OTHER

Milk powder product given to babies between 1 week and 4 months

Whey predominant starter formula + 50% palmitic acid

Whey predominant starter formula + 50% palmitic acid in sn-2 position

Group Type: EXPERIMENTAL

Whey predominant starter formula

Intervention Type: OTHER

Milk powder product given to babies between 1 week and 4 months

Interventions

Whey predominant starter formula

Milk powder product given to babies between 1 week and 4 months

Intervention Type: OTHER

Whey predominant starter formula + 40% palmitic acid

Milk powder product containing 40% of palmitic acid

Intervention Type: OTHER

Whey predominant starter formula + 50% palmitic acid

Milk powder product containing 50% of palmitic acid

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Turck, Prof

Role: PRINCIPAL_INVESTIGATOR

Gatroenterology and Nutrition, Pediatric dept, CHRU Lille

References

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.

Reference Type: DERIVED

PMID: 29903473 (View on PubMed)

Other Identifiers

06.16.INF

Identifier Type: -

Identifier Source: org_study_id