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Factors Influencing the Composition of Human Milk

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04382989
Enrollment
174
Registered
2020-05-11
Start date
2017-09-15
Completion date
2020-04-30
Last updated
2020-06-04

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

Conditions

Breast Milk Collection

Brief 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.

Detailed 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.

Interventions

DEVICEAnalysis 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.

Sponsors

University of Cagliari
CollaboratorOTHER
Vilnius University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Quantification of total protein concentration in human milkfrom the 2nd week, up to 2 months after deliveryMid-infrared spectrophotometry

Secondary

MeasureTime frameDescription
Quantification of total lipids and carbohydrate in human milkfrom the 2nd week, up to 2 months after deliveryMid-infrared spectrophotometry
Quantification of lactoferrin in human milk14-16 days after deliveryAn immune-enzymatic ELISA assay
Quantification of lysozyme in human milk14-16 days after deliveryAn immune-enzymatic ELISA assay
Human milk metabolome analysis15-17 days after deliveryNuclear Magnetic Resonance (NMR) analysis

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026