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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02112331
Acronym
ARCHILACT
Enrollment
20
Registered
2014-04-11
Start date
2014-04-30
Completion date
2016-04-30
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Preterm newborns, Gastric lipolysis, Physical treatments, Human milk

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.

Interventions

OTHERRaw human milk
OTHERPasteurized human milk
OTHERPasteurized-homogenized human milk
OTHERGastric samples

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Days to 21 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of triacylglycerol hydrolysis35 minMonitoring of the lipolysis kinetics, using chromatography methods

Secondary

MeasureTime frameDescription
Size distribution and specific surface of milk fat globule by laser light scattering35 min, 60 min, 90 min
Fat composition35 min, 60 min, 90 minFat composition by chromatographic techniques : High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC)
Lipolysis products35 min, 60 min, 90 minLipolysis products by thin layer chromatography (TLC), gas chromatography (GC) and IATROSCAN
Percentage of free fatty acids appearing35 min, 60 min, 90 minMonitoring of the lipolysis kinetics, using chromatography methods
Kinetic of the gastric emptying35 min, 60 min, 90 minEvaluation of the kinetic of the gastric emptying by measuring the volume remaining in the stomach
Lipolysis level35 min, 60 min, 90 minComparison of lipolysis level obtained either on in vitro or in vivo studies
Percentage of triacylglycerol hydrolysis60 min, 90 min
Proteolysis products35 min, 60 min, 90 minProteolysis products by electrophoresis (SDS-Page) and free amino acids by chromatography (HPLC)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026