Comparison of Macronutrient Content of Breast Milk Collected From Mothers Using Three Different Milking Methods

NCT07046962 | Completed

• 1 other identifier: Macronutrient
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the macronutrient content of mature milk obtained from mothers using three different methods: hand milking, manual pumping and electric machine. This study, which was conducted with an experimental design, included 31 mothers who met the sample criteria. The macronutrient content of mature milk obtained from mothers with term babies using three different milking methods was examined by providing the highest level of standardization in the sample. A nutrition plan was applied to the mothers three days before milk samples were taken and on the milking days. Milk was milked from the mothers according to the three different methods specified in the randomization one day apart. Data were obtained with the Introductory Information Form, Breast Milk Information Form, Breast Milk Follow-up Form and Daily Food Consumption Record Form. Frozen milk samples were analyzed with Miris® HMATM to determine protein, fat, carbohydrate and energy values. Data were analyzed using the R programming language version 4.4.1.

Conditions

Breastmilk; Breastmilk Expression; Breastmilk Collection; Human Milk/Breastfeeding; Macronutrients

Keywords

Anne sütü,; macrobesin,; protein,; yağ,; karbonhidrat

Outcome Measures

Primary Outcomes (4)

• Protein content of mature breast milk measured by Miris® Human Milk Analyzer™

  Breast milk samples collected from each mother (10 mL) were stored at -18 °C and later thawed by a Nutrition and Dietetics researcher at 0-4 °C within 24 hours in the Nutrition and Dietetics Department Laboratory. To ensure reliability, each milk sample was analyzed twice. The macronutrient content of the mature breast milk-including protein (g/100 mL) was determined using the Miris® Human Milk Analyzer™ (Miris AB, Uppsala, Sweden). The analysis results were recorded in the Breast Milk Tracking Form. Unit of Measure: Protein (g/100 mL)

  Three consecutive postpartum days (Days 23-25)

• Energy content of mature breast milk measured by Miris® Human Milk Analyzer™

  Breast milk samples collected from each mother (10 mL) were stored at -18 °C and later thawed by a Nutrition and Dietetics researcher at 0-4 °C within 24 hours in the Nutrition and Dietetics Department Laboratory. To ensure reliability, each milk sample was analyzed twice. The energy content of the mature breast milk-including energy (kcal/100 mL)-was determined using the Miris® Human Milk Analyzer™ (Miris AB, Uppsala, Sweden). The analysis results were recorded in the Breast Milk Tracking Form. "Breast milk energy content (kcal/100 mL).

  Three consecutive postpartum days (Days 23-25)

• Fat content of mature breast milk measured by Miris® Human Milk Analyzer™

  Breast milk samples collected from each mother (10 mL) were stored at -18 °C and later thawed by a Nutrition and Dietetics researcher at 0-4 °C within 24 hours in the Nutrition and Dietetics Department Laboratory. To ensure reliability, each milk sample was analyzed twice. The fat content of the mature breast milk-fat (g/100 mL) was determined using the Miris® Human Milk Analyzer™ (Miris AB, Uppsala, Sweden). The analysis results were recorded in the Breast Milk Tracking Form. "Breast milk Fat (g/100 mL).

  Three consecutive postpartum days (Days 23-25)

• Carbohydrate content of mature breast milk measured by Miris® Human Milk Analyzer™

  Breast milk samples collected from each mother (10 mL) were stored at -18 °C and later thawed by a Nutrition and Dietetics researcher at 0-4 °C within 24 hours in the Nutrition and Dietetics Department Laboratory. To ensure reliability, each milk sample was analyzed twice. The carbohydrate of the mature breast milk-including carbohydrate (g/100 mL), was determined using the Miris® Human Milk Analyzer™ (Miris AB, Uppsala, Sweden). The analysis results were recorded in the Breast Milk Tracking Form. "Breast milk carbohydrate content (g/100 mL), measured using Miris® Human Milk Analyzer Unit of Measure

  Three consecutive postpartum days (Days 23-25)

Secondary Outcomes (4)

• Comparison of energy content of breast milk by expression method (hand, manual pump, electric pump), measured by Miris® Human Milk Analyzer™

  Three consecutive postpartum days (Days 23-25)

• Comparison of protein content of breast milk by expression method (hand, manual pump, electric pump), measured by Miris® Human Milk Analyzer™

  Three consecutive postpartum days (Days 23-25)

• Comparison of fat content of breast milk by expression method (hand, manual pump, electric pump), measured by Miris® Human Milk Analyzer™

  Three consecutive postpartum days (Days 23-25)

• Comparison of Carbohydrate content of breast milk by expression method (hand, manual pump, electric pump), measured by Miris® Human Milk Analyzer™

  Three consecutive postpartum days (Days 23-25)

Study Arms (3)

Intervention Type Device: hand expressing breast milk

EXPERIMENTAL

Samples were taken by hand milking the mother's milk.

Other: Intervention Type Device: Hand pumping breast milk

Intervention Type Device: breast milk expression group with manual pump

EXPERIMENTAL

Breast milk was obtained with a manual pump.

Other: Intervention Type Device: Manual pump expressing breast milk

Intervention Type Device: expressing breast milk with electric pump

EXPERIMENTAL

Breast milk was expressed with an electric pump.

Other: Intervention Type Device: Electric pumping breast milk

Interventions

Intervention Type Device: Manual pump expressing breast milk OTHER

Since this study aimed to examine the macronutrient content of milks expressed from the same mother with three different methods, one day apart, the data collection process was carried out in stages. The methods determined by randomization were hand expressing breast milk, hand pumping and electric pumping. Hand expressing: Milk was expressed by hand until the milk flow stopped at the mother's breast. While the baby was sucking from one breast, the other breast was milked, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes.

Intervention Type Device: breast milk expression group with manual pump

Intervention Type Device: Hand pumping breast milk OTHER

Since this study aimed to examine the macronutrient content of milk expressed from the same mother with three different methods, one day apart, the data collection process was carried out in stages. The methods determined by randomization were hand expressing breast milk, manual pump expressing and electric pump expressing. Manual pump expressing: Milk was expressed with a manual pump until the milk flow stopped in the mother's breast. While the baby was sucking from one breast, the other breast was milked, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes.

Intervention Type Device: hand expressing breast milk

Intervention Type Device: Electric pumping breast milk OTHER

Since this study aimed to examine the macronutrient content of milk expressed from the same mother with three different methods, one day apart, the data collection process was carried out in stages. The methods determined by randomization were hand expressing breast milk, manual pump expressing and electric pump expressing. Electric pump expressing: Milk was expressed with an electric pump until the milk flow stopped in the mother's breast. While the baby was sucking from one breast, the other breast was milked, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes.

Intervention Type Device: expressing breast milk with electric pump

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Breast milk samples were taken from lactating mothers.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The mother must be primigravida
• The mother must have given birth normally
• The mother must be breastfeeding her baby only
• The mother must not have a diagnosed health problem related to nutrition
• The mother must be open to communication and cooperation
• The mother must volunteer to participate in the study
• The mother must be at least literate
• The mother must be over the age of 18
• The mother must not be a vegetarian
• The mother must not smoke
• The mother must not have a diagnosed breast trauma (mastitis, abscess, etc.) - The mother must not use any herbal tea or medication other than the doctor's recommendation
• The mother's body mass index must be within normal values (18.5 to 24.9) before pregnancy (WHO, 2015).
• The mother must not be an immigrant/refugee/asylum seeker - The mother must have a smartphone and internet access

You may not qualify if:

• The mother wants to leave the study
• The mother has a sudden trauma/health problem that prevents her from participating in the study
• The mother has moved to another city
• The mother has an anatomical condition that prevents breastfeeding in both breasts (absence of breast, burn, loss of breast tissue, etc.)
• The mother is an athlete

Sponsors & Collaborators

• Sakarya University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Harran University

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Hülya Karataş, Professor

  Harran University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 2, 2025
• Study Start: August 30, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)