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Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns (ARCHILACT)

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Raw human milk
Pasteurized human milk
Pasteurized-homogenized human milk
Gastric samples
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Birth focused on measuring Preterm newborns, Gastric lipolysis, Physical treatments, Human milk

Eligibility Criteria

5 Days - 21 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Digestive congenital anomalies
  • Antecedent of enterocolitis
  • Patient included in other study
  • Abdominal distension on Day 0
  • Treatment by morphine or catecholamine on Day 0

Sites / Locations

  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Raw human milk / pasteurized human milk

Pasteurized human milk / pasteurized-homogenized human milk

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of triacylglycerol hydrolysis
Monitoring of the lipolysis kinetics, using chromatography methods

Secondary Outcome Measures

Size distribution and specific surface of milk fat globule by laser light scattering
Fat composition
Fat composition by chromatographic techniques : High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC)
Lipolysis products
Lipolysis products by thin layer chromatography (TLC), gas chromatography (GC) and IATROSCAN
Proteolysis products
Proteolysis products by electrophoresis (SDS-Page) and free amino acids by chromatography (HPLC)
Kinetic of the gastric emptying
Evaluation of the kinetic of the gastric emptying by measuring the volume remaining in the stomach
Lipolysis level
Comparison of lipolysis level obtained either on in vitro or in vivo studies
Percentage of triacylglycerol hydrolysis
Percentage of free fatty acids appearing
Monitoring of the lipolysis kinetics, using chromatography methods

Full Information

First Posted
March 25, 2014
Last Updated
May 19, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02112331
Brief Title
Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
Acronym
ARCHILACT
Official Title
Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Preterm newborns, Gastric lipolysis, Physical treatments, Human milk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raw human milk / pasteurized human milk
Arm Type
Experimental
Arm Description
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.
Arm Title
Pasteurized human milk / pasteurized-homogenized human milk
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Raw human milk
Intervention Type
Other
Intervention Name(s)
Pasteurized human milk
Intervention Type
Other
Intervention Name(s)
Pasteurized-homogenized human milk
Intervention Type
Other
Intervention Name(s)
Gastric samples
Primary Outcome Measure Information:
Title
Percentage of triacylglycerol hydrolysis
Description
Monitoring of the lipolysis kinetics, using chromatography methods
Time Frame
35 min
Secondary Outcome Measure Information:
Title
Size distribution and specific surface of milk fat globule by laser light scattering
Time Frame
35 min, 60 min, 90 min
Title
Fat composition
Description
Fat composition by chromatographic techniques : High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC)
Time Frame
35 min, 60 min, 90 min
Title
Lipolysis products
Description
Lipolysis products by thin layer chromatography (TLC), gas chromatography (GC) and IATROSCAN
Time Frame
35 min, 60 min, 90 min
Title
Proteolysis products
Description
Proteolysis products by electrophoresis (SDS-Page) and free amino acids by chromatography (HPLC)
Time Frame
35 min, 60 min, 90 min
Title
Kinetic of the gastric emptying
Description
Evaluation of the kinetic of the gastric emptying by measuring the volume remaining in the stomach
Time Frame
35 min, 60 min, 90 min
Title
Lipolysis level
Description
Comparison of lipolysis level obtained either on in vitro or in vivo studies
Time Frame
35 min, 60 min, 90 min
Title
Percentage of triacylglycerol hydrolysis
Time Frame
60 min, 90 min
Title
Percentage of free fatty acids appearing
Description
Monitoring of the lipolysis kinetics, using chromatography methods
Time Frame
35 min, 60 min, 90 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Days
Maximum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Digestive congenital anomalies Antecedent of enterocolitis Patient included in other study Abdominal distension on Day 0 Treatment by morphine or catecholamine on Day 0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Pladys, MD, PhD
Organizational Affiliation
Pôle de pédiatrie, CHU de Rennes, FRANCE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier Dupont
Organizational Affiliation
Agrocampus Ouest - Département AgroAlimentaire UMR 1253 INRA " Science et Technologie du Lait et de l'Oeuf ", Rennes, FRANCE
Official's Role
Study Chair
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27283620
Citation
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.
Results Reference
background
PubMed Identifier
29072162
Citation
de 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.
Results Reference
derived
PubMed Identifier
28052887
Citation
de 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.
Results Reference
derived

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Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns

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