Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

January 12, 2015 updated by: Nestlé
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 4 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Whey predominant starter formula
Milk powder product containing 40% of palmitic acid
Milk powder product containing 50% of palmitic acid
EXPERIMENTAL: Whey predominant starter formula + 40% palmitic acid
Whey predominant starter formula + 40% palmitic acid in sn-2 position
Milk powder product given to babies between 1 week and 4 months
EXPERIMENTAL: Whey predominant starter formula + 50% palmitic acid
Whey predominant starter formula + 50% palmitic acid in sn-2 position
Milk powder product given to babies between 1 week and 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool consistency
Time Frame: 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.
4 months
Baby weight gain
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 months
To assess the infants' digestive tolerance of the starter formula
4 months
Gut microbiota using microbiology method
Time Frame: 4 months
To compare gut microbiota between the groups
4 months
Fat quantity in the stools
Time Frame: 4 months
To assess fat absorption
4 months
Baby body composition (DEXA)
Time Frame: 4 months
To compare body composition
4 months
Food intake by the baby
Time Frame: 4 months
To compare volume intake between the groups
4 months
Rate of spitting up
Time Frame: 4 months
To compare spitting up between the groups
4 months
Number of adverse events
Time Frame: 4 months
To evaluate the frequency of episodes of morbidity (adverse events)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Dominique Turck, Prof, Gatroenterology and Nutrition, Pediatric dept, CHRU Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (ESTIMATE)

January 7, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 06.16.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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