Factors Influencing the Composition of Human Milk

Breast Milk Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382989
• Other study ID #: MPS-2017
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2020
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

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Exclusion Criteria:

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

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Related Conditions & MeSH terms

• Breast Milk Collection

Intervention

Device:
• Analysis of human milk composition by mid-infrared spectrophotometry
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.

Locations

Country	Name	City	State
Lithuania	Neonatal centre of Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	University of Cagliari

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of total protein concentration in human milk	Mid-infrared spectrophotometry	from the 2nd week, up to 2 months after delivery
Secondary	Quantification of total lipids and carbohydrate in human milk	Mid-infrared spectrophotometry	from the 2nd week, up to 2 months after delivery
Secondary	Quantification of lactoferrin in human milk	An immune-enzymatic ELISA assay	14-16 days after delivery
Secondary	Quantification of lysozyme in human milk	An immune-enzymatic ELISA assay	14-16 days after delivery
Secondary	Human milk metabolome analysis	Nuclear Magnetic Resonance (NMR) analysis	15-17 days after delivery