Premature BirthARCHILACTNCT02112331
Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
A study testing Raw human milk, Pasteurized human milk and Pasteurized-homogenized human milk in people with Premature Birth, run by Rennes University Hospital at 1 site in France.
Trial summary
The optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. Human milk is considered as the best food for newborns. Read more about this study
- Who is it for?
- Ages 5 to 21 days
- Conditions the study is for
- Premature Birth
- What is being tested?
- Raw human milk, Pasteurized human milk and Pasteurized-homogenized human milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2016
- 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 5 to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature neonates born before 32 weeks of gestation
- Newborn dwelled near Rennes
- Volume of enteral nutrition > 120 mL/kg/j (Day 0)
- Written-informed parental consent for the study
Who cannot join
- Digestive congenital anomalies
- Antecedent of enterocolitis
- Patient included in other study
- Abdominal distension on Day 0
- Treatment by morphine or catecholamine on Day 0
Trial locations and contacts
1 site in 1 country.
About this study
The optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. Human milk is considered as the best food for newborns. Several short and long-term beneficial health effects were attributed to breastfeeding and have induced the increase of human milk in preterm newborns nutrition.
Whereas the chemical composition of infant formula has been optimized to mimic human milk, there is still a major difference between the structure of human milk and commercial infant formulas. It is well known in adult nutrition that the structure of emulsions influences their susceptibility to hydrolysis, such results have been obtained either on in vitro or in vivo studies.
Read more
Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids, sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.
The physical treatments apply to human milk or more generally to bovine milk to pasteurize or stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance induces whey proteins denaturation and the adsorption of protein aggregates on the surface of the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated lipase. These effects limit intragastric lipolysis in preterm newborns.
Conversely, reduction of milk globules size, by homogenisation of milk, increases the specific surface available for lipase adsorption and limits the lost of fat during enteral administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat absorption of preterm newborns.
The objective of this trial is to evaluate the effects of physical treatments (pasteurization and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk destructuration. This trial is conducted, in vivo, on preterm newborns.
- Conditions
- Premature Birth
- Being tested
- Raw human milk, Pasteurized human milk, Pasteurized-homogenized human milk, Gastric samples
- Keywords
- Preterm newborns, Gastric lipolysis, Physical treatments, Human milk
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raw human milkOther
Pasteurized human milkOther
Pasteurized-homogenized human milkOther
Gastric samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Raw human milk / pasteurized human milk | Experimental | Raw human milk compared to pasteurized human milk. Two meals administration (20mL/kg) per day during 6 days in a randomized order, with an intragastric tube : one with raw milk and one with pasteurized milk.
In order to characterise gastric effluents at different postprandial times after ingestion and to measure gastric lipolysis and proteolysis, at each administration two gastric samples will be collected with the intragastric tube :
* one before the meal,
* and one either 35, 60 or 90 minutes (randomized time frame) after the meal. Receives: Other: Raw human milk; Other: Pasteurized human milk; Other: Gastric samples |
| Pasteurized human milk / pasteurized-homogenized human milk | Experimental | Pasteurized human milk compared to pasteurized-homogenized human milk. Two meals administration (20mL/kg) per day during 6 days in a randomized order, with an intragastric tube : one with pasteurized milk and one with pasteurized-homogenized milk.
In order to characterise gastric effluents at different postprandial times after ingestion and to measure gastric lipolysis and proteolysis, at each administration two gastric samples will be collected with the intragastric tube :
* one before the meal,
* and one either 35, 60 or 90 minutes (randomized time frame) after the meal. Receives: Other: Pasteurized human milk; Other: Pasteurized-homogenized human milk; Other: Gastric samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of triacylglycerol hydrolysis
Monitoring of the lipolysis kinetics, using chromatography methods
Measured: 35 min
Secondary outcomes (8)
Size distribution and specific surface of milk fat globule by laser light scattering
Measured: 35 min, 60 min, 90 min
Fat composition
Fat composition by chromatographic techniques : High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC)
Measured: 35 min, 60 min, 90 min
Lipolysis products
Lipolysis products by thin layer chromatography (TLC), gas chromatography (GC) and IATROSCAN
Measured: 35 min, 60 min, 90 min
Proteolysis products
Proteolysis products by electrophoresis (SDS-Page) and free amino acids by chromatography (HPLC)
Measured: 35 min, 60 min, 90 min
Kinetic of the gastric emptying
Evaluation of the kinetic of the gastric emptying by measuring the volume remaining in the stomach
Measured: 35 min, 60 min, 90 min
Lipolysis level
Comparison of lipolysis level obtained either on in vitro or in vivo studies
Measured: 35 min, 60 min, 90 min
Percentage of triacylglycerol hydrolysis
Measured: 60 min, 90 min
Percentage of free fatty acids appearing
Monitoring of the lipolysis kinetics, using chromatography methods
Measured: 35 min, 60 min, 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Pladys, MD, PhD, Principal investigator, Pôle de pédiatrie, CHU de Rennes, FRANCEDidier Dupont, Study chair, Agrocampus Ouest - Département AgroAlimentaire UMR 1253 INRA " Science et Technologie du Lait et de l'Oeuf ", Rennes, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112331
- Sponsor's protocol ID
- 2013-A01460-45
- Acronym
- ARCHILACT
- Status last verified
- May 2023
- First submitted
- 25 Mar 2014
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
de Oliveira SC, Bourlieu C, Menard O, Bellanger A, Henry G, Rousseau F, Dirson E, Carriere F, Dupont D, Deglaire A. Impact of pasteurization of human milk on preterm newborn in vitro digestion: Gastrointestinal disintegration, lipolysis and proteolysis. Food Chem. 2016 Nov 15;211:171-9. doi: 10.1016/j.foodchem.2016.05.028. Epub 2016 May 6.
PubMed 27283620de Oliveira SC, Bellanger A, Menard O, Pladys P, Le Gouar Y, Henry G, Dirson E, Rousseau F, Carriere F, Dupont D, Bourlieu C, Deglaire A. Impact of homogenization of pasteurized human milk on gastric digestion in the preterm infant: A randomized controlled trial. Clin Nutr ESPEN. 2017 Aug;20:1-11. doi: 10.1016/j.clnesp.2017.05.001. Epub 2017 May 15.
PubMed 29072162de Oliveira SC, Bellanger A, Menard O, Pladys P, Le Gouar Y, Dirson E, Kroell F, Dupont D, Deglaire A, Bourlieu C. Impact of human milk pasteurization on gastric digestion in preterm infants: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):379-390. doi: 10.3945/ajcn.116.142539. Epub 2017 Jan 4.
PubMed 28052887
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
- ClinicalTrials.gov ID
- NCT02112331
- Acronym / sponsor ID
- ARCHILACT / 2013-A01460-45
- Conditions
- Premature Birth
- Keywords
- Preterm newborns, Gastric lipolysis, Physical treatments, Human milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Apr 2014 (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 optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. Human milk is considered as the best food for newborns. Several short and long-term beneficial health effects were attributed to breastfeeding and have induced the increase of human milk in preterm newborns nutrition.
Whereas the chemical composition of infant formula has been optimized to mimic human milk, there is still a major difference between the structure of human milk and commercial infant formulas. It is well known in adult nutrition that the structure of emulsions influences their susceptibility to hydrolysis, such results have been obtained either on in vitro or in vivo studies.
Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids, sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.
The physical treatments apply to human milk or more generally to bovine milk to pasteurize or stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance induces whey proteins denaturation and the adsorption of protein aggregates on the surface of the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated lipase. These effects limit intragastric lipolysis in preterm newborns.
Conversely, reduction of milk globules size, by homogenisation of milk, increases the specific surface available for lipase adsorption and limits the lost of fat during enteral administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat absorption of preterm newborns.
The objective of this trial is to evaluate the effects of physical treatments (pasteurization and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk destructuration. This trial is conducted, in vivo, on preterm newborns.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raw human milk / pasteurized human milk | Experimental | Other: Raw human milk, Other: Pasteurized human milk, Other: Gastric samplesRaw human milk compared to pasteurized human milk. Two meals administration (20mL/kg) per day during 6 days in a randomized order, with an intragastric tube : one with raw milk and one with pasteurized milk. In order to characterise gastric effluents at different postprandial times after ingestion and to measure gastric lipolysis and proteolysis, at each administration two gastric samples will be collected with the intragastric tube : * one before the meal, * and one either 35, 60 or 90 minutes (randomized time frame) after the meal. |
| Pasteurized human milk / pasteurized-homogenized human milk | Experimental | Other: Pasteurized human milk, Other: Pasteurized-homogenized human milk, Other: Gastric samplesPasteurized human milk compared to pasteurized-homogenized human milk. Two meals administration (20mL/kg) per day during 6 days in a randomized order, with an intragastric tube : one with pasteurized milk and one with pasteurized-homogenized milk. In order to characterise gastric effluents at different postprandial times after ingestion and to measure gastric lipolysis and proteolysis, at each administration two gastric samples will be collected with the intragastric tube : * one before the meal, * and one either 35, 60 or 90 minutes (randomized time frame) after the meal. |
Who may qualify
- Ages
- 5 to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature neonates born before 32 weeks of gestation
- Newborn dwelled near Rennes
- Volume of enteral nutrition > 120 mL/kg/j (Day 0)
- Written-informed parental consent for the study
Key exclusion criteria (5 listed)
- Digestive congenital anomalies
- Antecedent of enterocolitis
- Patient included in other study
- Abdominal distension on Day 0
- Treatment by morphine or catecholamine on Day 0
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 |
|---|---|---|
| Raw human milk | Other | Raw human milk / pasteurized human milk |
| Pasteurized human milk | Other | Pasteurized human milk / pasteurized-homogenized human milk, Raw human milk / pasteurized human milk |
| Pasteurized-homogenized human milk | Other | Pasteurized human milk / pasteurized-homogenized human milk |
| Gastric samples | Other | Pasteurized human milk / pasteurized-homogenized human milk, Raw human milk / pasteurized human milk |
Primary outcome
Percentage of triacylglycerol hydrolysis
Time frame: 35 min
Monitoring of the lipolysis kinetics, using chromatography methods
8 secondary outcomes
Size distribution and specific surface of milk fat globule by laser light scattering
Time frame: 35 min, 60 min, 90 min
Fat composition
Time frame: 35 min, 60 min, 90 min
Lipolysis products
Time frame: 35 min, 60 min, 90 min
Proteolysis products
Time frame: 35 min, 60 min, 90 min
Kinetic of the gastric emptying
Time frame: 35 min, 60 min, 90 min
Lipolysis level
Time frame: 35 min, 60 min, 90 min
Percentage of triacylglycerol hydrolysis
Time frame: 60 min, 90 min
Percentage of free fatty acids appearing
Time frame: 35 min, 60 min, 90 min
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 23 May 2023.
- Background: PubMed 27283620de Oliveira SC, Bourlieu C, Menard O, Bellanger A, Henry G, Rousseau F, Dirson E, Carriere F, Dupont D, Deglaire A. Impact of pasteurization of human milk on preterm newborn in vitro digestion: Gastrointestinal disintegration, lipolysis and proteolysis. Food Chem. 2016 Nov 15;211:171-9. doi: 10.1016/j.foodchem.2016.05.028. Epub 2016 May 6.
- Derived from this study: PubMed 29072162de Oliveira SC, Bellanger A, Menard O, Pladys P, Le Gouar Y, Henry G, Dirson E, Rousseau F, Carriere F, Dupont D, Bourlieu C, Deglaire A. Impact of homogenization of pasteurized human milk on gastric digestion in the preterm infant: A randomized controlled trial. Clin Nutr ESPEN. 2017 Aug;20:1-11. doi: 10.1016/j.clnesp.2017.05.001. Epub 2017 May 15.
- Derived from this study: PubMed 28052887de Oliveira SC, Bellanger A, Menard O, Pladys P, Le Gouar Y, Dirson E, Kroell F, Dupont D, Deglaire A, Bourlieu C. Impact of human milk pasteurization on gastric digestion in preterm infants: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):379-390. doi: 10.3945/ajcn.116.142539. Epub 2017 Jan 4.
Related trials for Premature Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Patrick Pladys, MD, PhD principal investigator
Pôle de pédiatrie, CHU de Rennes, FRANCE
Didier Dupont study chair
Agrocampus Ouest - Département AgroAlimentaire UMR 1253 INRA " Science et Technologie du Lait et de l'Oeuf ", Rennes, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raw human milk, Pasteurized human milk and Pasteurized-homogenized human milk in people with Premature Birth, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 5 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 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Percentage of triacylglycerol hydrolysis (time frame: 35 min). 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 NCT02112331, which also lists 3 linked publications.
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 23 May 2023.