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

Premature Birth Clinical Trial

— ARCHILACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112331
• Other study ID #: 2013-A01460-45
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Days to 21 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Raw human milk

• Pasteurized human milk

• Pasteurized-homogenized human milk

• Gastric samples

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

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

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