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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Nutrition and Neurological Development of Very Preterm Infants

NCT01486173

Infant, Premature, Diseases Infant Nutrition Disorders Development; Delayed, Mental

UNKNOWN

Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns

NCT01177475

Premature Birth

COMPLETED NA

Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.

NCT02997826

Child Development

COMPLETED NA

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

NCT07096011

Infant Body Composition and Metabolism Metabolism Energy Expenditure +3 more

RECRUITING

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

NCT06212427

Premature Infant Low Birthweight Infant

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Raw human milk / pasteurized human milk

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.

Group Type EXPERIMENTAL

Raw human milk

Intervention Type OTHER

Pasteurized human milk

Intervention Type OTHER

Gastric samples

Intervention Type OTHER

Pasteurized human milk / pasteurized-homogenized human milk

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.

Group Type EXPERIMENTAL

Pasteurized human milk

Intervention Type OTHER

Pasteurized-homogenized human milk

Intervention Type OTHER

Gastric samples

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Raw human milk

Intervention Type OTHER

Pasteurized human milk

Intervention Type OTHER

Pasteurized-homogenized human milk

Intervention Type OTHER

Gastric samples

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Days

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No