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Completed

NCT Number: NCT04382989

Factors Influencing the Composition of Human Milk

This study aims for characterization of different maternal, infant and environmental factors (e.g. maternal age, pregnancy duration, lactation period, baby gender, circadian rhythm, Holder pasteurisation, etc.) that influence human milk composition.

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Key information

Conditions

Breast Milk Collection Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Sex eligibility

Female

Study type

Observational

Primary location

Neonatal centre of Vilnius University Hospital Santaros Klinikos

Vilnius, 08406, Lithuania

About this study

The study consists of three parts. In the first part the investigators aim to evaluate human milk macronutrient composition depending on the time after delivery and pregnancy duration.

In the second part the investigators aim to evaluate the circadian variation of human milk macronutrient and energy content depending on pregnancy duration.

In the third part the investigators aim to evaluate the influence of Holder pasteurisation on human milk macronutrient, metabolome and bioactive protein (lysozyme and lactoferrin) content.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

having obtained informed consent; after a single-birth pregnancy; women who were not on a special diet; lactating mothers who could not breastfeed their newborns due to the baby's medical condition (either prematurity or disease) but who expressed milk.

-

Exclusion criteria

breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.

-

Treatment and study plan

Analysis of human milk composition by mid-infrared spectrophotometry

Device

Analysis of human milk macronutrient content was performed by mid-infrared spectrophotometry using a Miris Human Milk Analyser.

An immune-enzymatic ELISA assays were used to estimate lysozyme and lactoferrin concentrations in human milk.

Other names: Holder pasteurisation

Primary outcomes

  1. Quantification of total protein concentration in human milk

    Time frame: from the 2nd week, up to 2 months after delivery

    Mid-infrared spectrophotometry

Secondary outcomes

  1. Quantification of total lipids and carbohydrate in human milk

    Time frame: from the 2nd week, up to 2 months after delivery

    Mid-infrared spectrophotometry

  2. Quantification of lactoferrin in human milk

    Time frame: 14-16 days after delivery

    An immune-enzymatic ELISA assay

  3. Quantification of lysozyme in human milk

    Time frame: 14-16 days after delivery

    An immune-enzymatic ELISA assay

  4. Human milk metabolome analysis

    Time frame: 15-17 days after delivery

    Nuclear Magnetic Resonance (NMR) analysis

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • University of Cagliari

Registry information

Official study title

The Influence of Various Maternal, Infant and Environmental Factors on Human Milk Composition Among Lithuanian Women

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 11, 2020
Registry last updated
Jun 4, 2020

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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