Factors Influencing the Composition of Human Milk
- Conditions
- Breast Milk Collection
- Registration Number
- NCT04382989
- Lead Sponsor
- Vilnius University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 174
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.
breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantification of total protein concentration in human milk from the 2nd week, up to 2 months after delivery Mid-infrared spectrophotometry
- Secondary Outcome Measures
Name Time Method Quantification of lysozyme in human milk 14-16 days after delivery An immune-enzymatic ELISA assay
Quantification of lactoferrin in human milk 14-16 days after delivery An immune-enzymatic ELISA assay
Quantification of total lipids and carbohydrate in human milk from the 2nd week, up to 2 months after delivery Mid-infrared spectrophotometry
Human milk metabolome analysis 15-17 days after delivery Nuclear Magnetic Resonance (NMR) analysis
Trial Locations
- Locations (1)
Neonatal centre of Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
Neonatal centre of Vilnius University Hospital Santaros Klinikos🇱🇹Vilnius, Lithuania