- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332967
Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Dominique Turck, Prof, Gatroenterology and Nutrition, Pediatric dept, CHRU Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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