Clinical trial NCT02112331: Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
Official title: Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Preterm newborns
Gastric lipolysis
Physical treatments
Human milk
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Percentage of triacylglycerol hydrolysis
timeFrame: 35 min
Secondary outcomes:
measure: Size distribution and specific surface of milk fat globule by laser light scattering
timeFrame: 35 min, 60 min, 90 min
measure: Fat composition
timeFrame: 35 min, 60 min, 90 min
measure: Lipolysis products
timeFrame: 35 min, 60 min, 90 min
measure: Proteolysis products
timeFrame: 35 min, 60 min, 90 min
measure: Kinetic of the gastric emptying
timeFrame: 35 min, 60 min, 90 min
measure: Lipolysis level
timeFrame: 35 min, 60 min, 90 min
measure: Percentage of triacylglycerol hydrolysis
timeFrame: 60 min, 90 min
measure: Percentage of free fatty acids appearing
timeFrame: 35 min, 60 min, 90 min
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Pôle de pédiatrie, CHU de Rennes, FRANCE
name: Patrick Pladys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agrocampus Ouest - Département AgroAlimentaire UMR 1253 INRA " Science et Technologie du Lait et de l'Oeuf ", Rennes, FRANCE
name: Didier Dupont
role: STUDY_CHAIR
References:
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.
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.
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.