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

NCT02112331 | Completed

• 1 other identifier: 2013-A01460-45
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Preterm newborns; Gastric lipolysis; Physical treatments; Human milk

Outcome Measures

Primary Outcomes (1)

• Percentage of triacylglycerol hydrolysis

  Monitoring of the lipolysis kinetics, using chromatography methods

  35 min

Secondary Outcomes (8)

• Size distribution and specific surface of milk fat globule by laser light scattering

  35 min, 60 min, 90 min

• Fat composition

  35 min, 60 min, 90 min

• Lipolysis products

  35 min, 60 min, 90 min

• Proteolysis products

  35 min, 60 min, 90 min

• Kinetic of the gastric emptying

  35 min, 60 min, 90 min

Study Arms (2)

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.

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.

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

Interventions

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

Eligibility Criteria

• Age: 5 Days - 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

Related Publications (3)

• 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.

  PMID: 27283620 BACKGROUND

• 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.

  PMID: 29072162 DERIVED

• 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.

  PMID: 28052887 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Patrick Pladys, MD, PhD

  Pôle de pédiatrie, CHU de Rennes, FRANCE

  PRINCIPAL INVESTIGATOR

• Didier Dupont

  Agrocampus Ouest - Département AgroAlimentaire UMR 1253 INRA " Science et Technologie du Lait et de l'Oeuf ", Rennes, FRANCE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

FR (1)