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

May 19, 2023 updated by: Rennes University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Rennes University Hospital

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

5 days to 3 weeks (Child)

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raw human milk / pasteurized human milk

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.
Other: Raw human milk
Other: Pasteurized human milk
Other: Gastric samples
Experimental: Pasteurized human milk / pasteurized-homogenized human milk

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.
Other: Pasteurized human milk
Other: Gastric samples
Other: Pasteurized-homogenized human milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of triacylglycerol hydrolysis
Time Frame: 35 min
Monitoring of the lipolysis kinetics, using chromatography methods
35 min

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Patrick Pladys, MD, PhD, Pôle de pédiatrie, CHU de Rennes, FRANCE
  • Study Chair: Didier Dupont, Agrocampus Ouest - Département AgroAlimentaire UMR 1253 INRA " Science et Technologie du Lait et de l'Oeuf ", Rennes, FRANCE

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.

General Publications

Helpful Links

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

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01460-45

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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