Comparison of Macronutrient Content of Breast Milk Collected From Mothers Using Three Different M… (NCT07046962) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Macronutrient Content of Breast Milk Collected From Mothers Using Three Different Milking Methods
Turkey (Türkiye)31 participantsStarted 2023-08-30
Plain-language 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.
Who can participate
Age range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The Inclusion Criteria for Mothers in the Study Sample;
* 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
Exclusion Criteria:
* Exclusion Criteria for Mothers:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared three different milking methods and looked at how they affect the protein, fat, carbohydrate, and energy content of breast milk — could you explain what those differences might mean for my baby's nutrition, and whether the milking method I'm currently using could be affecting the quality of my milk?
2Since this trial is already completed, are the results available, and if so, what did they find about which milking method best preserves the nutritional content of breast milk?
3The study used a specialized device called the Miris® Human Milk Analyzer to measure milk composition — is there any way for me to get my own breast milk tested for macronutrient content, especially if I'm concerned my baby isn't getting enough nutrition?
4If the findings from this study suggest one milking method is nutritionally superior to others, is that something worth factoring into my own pumping or hand-expression routine, and would you recommend I make any changes based on that?
5Are there other factors in my specific situation — like how often I pump, how I store my milk, or my own diet — that might affect my milk's nutritional quality in ways that go beyond what this study measured?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protein content of mature breast milk measured by Miris® Human Milk Analyzer™
Timeframe: Three consecutive postpartum days (Days 23-25)
2
Energy content of mature breast milk measured by Miris® Human Milk Analyzer™
Timeframe: Three consecutive postpartum days (Days 23-25)
3
Fat content of mature breast milk measured by Miris® Human Milk Analyzer™
Timeframe: Three consecutive postpartum days (Days 23-25)
4
Carbohydrate content of mature breast milk measured by Miris® Human Milk Analyzer™
Timeframe: Three consecutive postpartum days (Days 23-25)