Healthy Newborn InfantsNCT02332967
Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
A study testing Whey predominant starter formula, Whey predominant starter formula + 40% palmitic acid and Whey predominant starter formula + 50% palmitic acid in people with Healthy Newborn Infants, run by Société des Produits Nestlé (SPN).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Newborn Infants
- What is being tested?
- Whey predominant starter formula, Whey predominant starter formula + 40% palmitic acid and Whey predominant starter formula + 50% palmitic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- Whey predominant starter formula, Whey predominant starter formula + 40% palmitic acid, Whey predominant starter formula + 50% palmitic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey predominant starter formulaOther
Milk powder product given to babies between 1 week and 4 months
Whey predominant starter formula + 40% palmitic acidOther
Milk powder product containing 40% of palmitic acid
Whey predominant starter formula + 50% palmitic acidOther
Milk powder product containing 50% of palmitic acid
| Study group | Role | What they receive |
|---|---|---|
| Whey predominant starter formula | Active comparator | Whey predominant starter formula Receives: Other: Whey predominant starter formula + 40% palmitic acid; Other: Whey predominant starter formula + 50% palmitic acid |
| Whey predominant starter formula + 40% palmitic acid | Experimental | Whey predominant starter formula + 40% palmitic acid in sn-2 position Receives: Other: Whey predominant starter formula |
| Whey predominant starter formula + 50% palmitic acid | Experimental | Whey predominant starter formula + 50% palmitic acid in sn-2 position Receives: Other: Whey predominant starter formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 months
Secondary outcomes (8)
Baby length and head circumference
To assess whether the groups have comparable changes in length, and head circumference
Measured: 4 months
Digestive tolerance using a questionnaire filled in by the mothers
To assess the infants' digestive tolerance of the starter formula
Measured: 4 months
Gut microbiota using microbiology method
To compare gut microbiota between the groups
Measured: 4 months
Fat quantity in the stools
To assess fat absorption
Measured: 4 months
Baby body composition (DEXA)
To compare body composition
Measured: 4 months
Food intake by the baby
To compare volume intake between the groups
Measured: 4 months
Rate of spitting up
To compare spitting up between the groups
Measured: 4 months
Number of adverse events
To evaluate the frequency of episodes of morbidity (adverse events)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJul 2007
- Primary completionFeb 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Newborn InfantsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominique Turck, Prof, Principal investigator, Gatroenterology and Nutrition, Pediatric dept, CHRU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332967
- Sponsor's protocol ID
- 06.16.INF
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29903473
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
- ClinicalTrials.gov ID
- NCT02332967
- Acronym / sponsor ID
- 06.16.INF
- Conditions
- Healthy Newborn Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey predominant starter formula | Active comparator | Other: Whey predominant starter formula + 40% palmitic acid, Other: Whey predominant starter formula + 50% palmitic acidWhey predominant starter formula |
| Whey predominant starter formula + 40% palmitic acid | Experimental | Other: Whey predominant starter formulaWhey predominant starter formula + 40% palmitic acid in sn-2 position |
| Whey predominant starter formula + 50% palmitic acid | Experimental | Other: Whey predominant starter formulaWhey predominant starter formula + 50% palmitic acid in sn-2 position |
Who may qualify
- Ages
- 1 week to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey predominant starter formulaMilk powder product given to babies between 1 week and 4 months | Other | Whey predominant starter formula + 40% palmitic acid, Whey predominant starter formula + 50% palmitic acid |
| Whey predominant starter formula + 40% palmitic acidMilk powder product containing 40% of palmitic acid | Other | Whey predominant starter formula |
| Whey predominant starter formula + 50% palmitic acidMilk powder product containing 50% of palmitic acid | Other | Whey predominant starter formula |
Primary outcome
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.
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
8 secondary outcomes
Baby length and head circumference
Time frame: 4 months
Digestive tolerance using a questionnaire filled in by the mothers
Time frame: 4 months
Gut microbiota using microbiology method
Time frame: 4 months
Fat quantity in the stools
Time frame: 4 months
Baby body composition (DEXA)
Time frame: 4 months
Food intake by the baby
Time frame: 4 months
Rate of spitting up
Time frame: 4 months
Number of adverse events
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Derived from this study: PubMed 29903473Beghin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Turck, Prof principal investigator
Gatroenterology and Nutrition, Pediatric dept, CHRU Lille
Questions about this trial
What is this clinical trial studying?
A study testing Whey predominant starter formula, Whey predominant starter formula + 40% palmitic acid and Whey predominant starter formula + 50% palmitic acid in people with Healthy Newborn Infants, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool consistency (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.