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Clinical Trials/NCT04382989
NCT04382989
Completed
Not Applicable

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

Vilnius University1 site in 1 country174 target enrollmentSeptember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Milk Collection
Sponsor
Vilnius University
Enrollment
174
Locations
1
Primary Endpoint
Quantification of total protein concentration in human milk
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2017
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Quantification of lysozyme in human milk(14-16 days after delivery)
  • Quantification of lactoferrin in human milk(14-16 days after delivery)
  • Quantification of total lipids and carbohydrate in human milk(from the 2nd week, up to 2 months after delivery)
  • Human milk metabolome analysis(15-17 days after delivery)

Study Sites (1)

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