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Completed

NCT Number: NCT02112331

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

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.

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Key information

Age range

5 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raw human milk

Other

Pasteurized human milk

Other

Pasteurized-homogenized human milk

Other

Gastric samples

Other

Primary outcomes

  1. Percentage of triacylglycerol hydrolysis

    Time frame: 35 min

    Monitoring of the lipolysis kinetics, using chromatography methods

Secondary outcomes

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

    Time frame: 35 min, 60 min, 90 min

  2. Fat composition

    Time frame: 35 min, 60 min, 90 min

    Fat composition by chromatographic techniques : High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC)

  3. Lipolysis products

    Time frame: 35 min, 60 min, 90 min

    Lipolysis products by thin layer chromatography (TLC), gas chromatography (GC) and IATROSCAN

  4. Proteolysis products

    Time frame: 35 min, 60 min, 90 min

    Proteolysis products by electrophoresis (SDS-Page) and free amino acids by chromatography (HPLC)

  5. 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

  6. Lipolysis level

    Time frame: 35 min, 60 min, 90 min

    Comparison of lipolysis level obtained either on in vitro or in vivo studies

  7. Percentage of triacylglycerol hydrolysis

    Time frame: 60 min, 90 min

  8. Percentage of free fatty acids appearing

    Time frame: 35 min, 60 min, 90 min

    Monitoring of the lipolysis kinetics, using chromatography methods

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ARCHILACT

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 11, 2014
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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