BreastmilkNCT07036094
Relationship Between Nutritional Consumption of Breastfeeding Mothers and Breast Milk Composition During Lactation
A study testing Manual breast milk expression in people with Breastmilk and Breastmilk Expression, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study seeks to answer the question of the effect of maternal diet during lactation on breast milk composition. This study was conducted with 31 mothers who were hospitalized in Şanlıurfa Education and Research Hospital due to childbirth between 2024-2025. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastmilk, Breastmilk Expression, Maternal Nutrition
- What is being tested?
- Manual breast milk expression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - The mother is primigravida
- The mother has given birth naturally
- The mother is only breastfeeding her baby
- The mother is over 19 years old
- The mother's body mass index is within normal values (18.5 to 24.9)
Who cannot join
- The mother wants to quit her job.
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to answer the question of the effect of maternal diet during lactation on breast milk composition. This study was conducted with 31 mothers who were hospitalized in Şanlıurfa Education and Research Hospital due to childbirth between 2024-2025. A nutrition plan was applied to the mothers three days before milk samples were taken and on milking days. Milk was milked by hand milking. 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.
Read the detailed description
Breast milk is the best source of nutrition for infants because it contains essential nutrients and other bioactive factors (e.g., hormones, antibodies, bioactive molecules, stem cells) in the right balance. The macronutrient values in breast milk of mature term babies have been reported as protein 0.9-1.2 gr/dl, fat 3.2-3.6 gr/dl, lactose 6.7-7.8 gr/dl. . It is known that exclusive breastfeeding in the first six months of life and breastfeeding with complementary foods at two years of age and beyond is associated with a reduced incidence of infections and chronic diseases . Studies have shown that breastfeeding has short- and long-term benefits and protective effects. It is known that breast milk protects the baby from chronic diseases, especially Type 1 and Type 2 diabetes, obesity, hypertension, cardiovascular diseases, hyperlipidemia and some types of cancer , has positive effects on the cognitive development of the baby , and this effect continues for many years. These protective effects are controversial and may differ according to maternal phenotypes . Compared to infant formulas with standardized compositions, the composition of breast milk changes dynamically because it is produced by women with significantly different genotypes and phenotypes . The composition of breast milk is affected by many maternal, infant and physiological factors. Some of these factors vary according to whether the baby is term or preterm, whether the milk is colostrum secreted in the first 5 days after birth, transitional milk secreted between 5 days and 2 weeks, and mature milk produced after the 2nd week, the mother's nutritional status, body mass index, parity, gender of the baby, birth weight of the baby, duration of breastfeeding, and the method of milk delivery (expressing/breastfeeding), etc.. However, the effect of maternal nutrition on breast milk composition has not been well defined. There are some limitations in previous studies evaluating the relationship between maternal factors and breast milk composition. These include the lack of standard milk expression protocols, no specific time (time of day, foremilk or hindmilk) for expressing milk samples , and exclusive breastfeeding or the lack of information on the analysis of milk composition. In addition, most of the existing studies were conducted in the 1980s and 1990s and did not use separate up-to-date analyzers for protein, fat and lactose for milk composition analysis. Bzikowska-Jura et al., (2018) investigated the relationship between maternal nutrition and breast milk composition. However, in this study, mothers used a mix of hand and manual milking methods and the time elapsed since the baby's last feeding, which is another factor that may affect the content of breast milk, was not specified. Due to all these methodological differences, the effect of maternal diet on breast milk composition has not been clarified. These limitations may affect the actual assessment of these relationships. In this context, our study seeks answers to the effect of maternal diet on breast milk composition.
- Conditions
- Breastmilk, Breastmilk Expression, Maternal Nutrition
- Being tested
- Manual breast milk expression
- Keywords
- human milk, maternal nutrition, lactation, breastmilk
- Medical subject headings
- Breast Milk Expression, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual breast milk expressionOther
Manual breast milk expression: Milk was expressed by hand until the milk flow stopped at the mother's breast. While the baby was suckling from one breast, milk was expressed from the other breast, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes.
The mothers' food records were analyzed for 3 days before the milk sample was taken and on the day the milk sample was taken.
| Study group | Role | What they receive |
|---|---|---|
| hand expressing breast milk | Experimental | Manual milking: Milk was expressed by hand until the milk flow stopped at the mother's breast. While the baby was suckling from one breast, milking was done from the other breast, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes. Receives: Other: Manual breast milk expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy of breast milk as measured by Miris® HMA™ 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-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), measured using Miris® Human Milk Analyzer Unit of Measure.
Measured: Postpartum 23rd day
Protein of breast milk as measured by Miris® HMA™ 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 Protein content of the mature breast milk-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. "Breast milk protein content (g/100 mL), measured using Miris® Human Milk Analyzer Unit of Measure.
Measured: Postpartum 23rd day
Fat of breast milk as measured by Miris® HMA™ 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 content (g/100 mL), measured using Miris® Human Milk Analyzer Unit of Measure.
Measured: Postpartum 23rd day
Carbohydrate of breast milk as measured by Miris® HMA™ 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 content of the mature breast milk-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.
Measured: Postpartum 23rd day
Daily maternal energy intake (kcal/day), calculated using BeBiS 8.0
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits. Energy intake was calculated in kilocalories and reported as average daily intake.
Protein: grams/100 mL
Energy: kcal/100 mL
24-Hour Dietary Recall Form
Measured: postpartum days 20, 21, and 22
Daily maternal protein intake (gram/day), calculated using BeBiS 8.0
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits.
Protein: grams/100 mL
24-Hour Dietary Recall Form
Measured: postpartum days 20, 21, and 22
Daily maternal fat intake (gram/day), calculated using BeBiS 8.0
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits.
Fat: grams/100 mL
24-Hour Dietary Recall Form
Measured: postpartum days 20, 21, and 22
Daily maternal Carbohydrate intake (gram/day), calculated using BeBiS 8.0
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits.
Carbohydrate : grams/100 mL
24-Hour Dietary Recall Form
Measured: postpartum days 20, 21, and 22
Secondary outcomes (4)
The correlation between maternal dietary intake protein and protein content of breast milk
The correlation between maternal dietary intake protein, and protein content of breast milk will be assessed using Pearson correlation analysis. Each dietary variable will be compared to its respective breast milk component.
Measured: Between matched maternal-milk pairs after the 23rd day postpartum
The correlation between maternal dietary intake energy and energy content of breast milk
The correlation between maternal dietary intake energy, and energy content of breast milk will be assessed using Pearson correlation analysis. Each dietary variable will be compared to its respective breast milk component.
Measured: Between matched maternal-milk pairs after the 23rd day postpartum
The correlation between maternal dietary intake fat and fat content of breast milk
The correlation between maternal dietary intake fat and fat content of breast milk will be assessed using Pearson correlation analysis. Each dietary variable will be compared to its respective breast milk component.
Measured: Between matched maternal-milk pairs after the 23rd day postpartum
The correlation between maternal dietary intake Carbohydrate and Carbohydrate content of breast milk
The correlation between maternal dietary intake Carbohydrate and Carbohydrate content of breast milk will be assessed using Pearson correlation analysis. Each dietary variable will be compared to its respective breast milk component.
Measured: Between matched maternal-milk pairs after the 23rd day postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start30 Aug 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastmilkStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor
- Investigators
- Hülya Karataş, Professor, Study director, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036094
- Sponsor's protocol ID
- Breast Milk Composition
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE STUDY MAY BE PUBLISHED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Nutritional Consumption of Breastfeeding Mothers and Breast Milk Composition During Lactation
- ClinicalTrials.gov ID
- NCT07036094
- Acronym / sponsor ID
- Breast Milk Composition
- Conditions
- Breastmilk, Breastmilk Expression, Maternal Nutrition
- Keywords
- human milk, maternal nutrition, lactation, breastmilk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to answer the question of the effect of maternal diet during lactation on breast milk composition. This study was conducted with 31 mothers who were hospitalized in Şanlıurfa Education and Research Hospital due to childbirth between 2024-2025. A nutrition plan was applied to the mothers three days before milk samples were taken and on milking days. Milk was milked by hand milking. 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.
Detailed description
Breast milk is the best source of nutrition for infants because it contains essential nutrients and other bioactive factors (e.g., hormones, antibodies, bioactive molecules, stem cells) in the right balance. The macronutrient values in breast milk of mature term babies have been reported as protein 0.9-1.2 gr/dl, fat 3.2-3.6 gr/dl, lactose 6.7-7.8 gr/dl. . It is known that exclusive breastfeeding in the first six months of life and breastfeeding with complementary foods at two years of age and beyond is associated with a reduced incidence of infections and chronic diseases . Studies have shown that breastfeeding has short- and long-term benefits and protective effects. It is known that breast milk protects the baby from chronic diseases, especially Type 1 and Type 2 diabetes, obesity, hypertension, cardiovascular diseases, hyperlipidemia and some types of cancer , has positive effects on the cognitive development of the baby , and this effect continues for many years. These protective effects are controversial and may differ according to maternal phenotypes . Compared to infant formulas with standardized compositions, the composition of breast milk changes dynamically because it is produced by women with significantly different genotypes and phenotypes . The composition of breast milk is affected by many maternal, infant and physiological factors. Some of these factors vary according to whether the baby is term or preterm, whether the milk is colostrum secreted in the first 5 days after birth, transitional milk secreted between 5 days and 2 weeks, and mature milk produced after the 2nd week, the mother's nutritional status, body mass index, parity, gender of the baby, birth weight of the baby, duration of breastfeeding, and the method of milk delivery (expressing/breastfeeding), etc.. However, the effect of maternal nutrition on breast milk composition has not been well defined. There are some limitations in previous studies evaluating the relationship between maternal factors and breast milk composition. These include the lack of standard milk expression protocols, no specific time (time of day, foremilk or hindmilk) for expressing milk samples , and exclusive breastfeeding or the lack of information on the analysis of milk composition. In addition, most of the existing studies were conducted in the 1980s and 1990s and did not use separate up-to-date analyzers for protein, fat and lactose for milk composition analysis. Bzikowska-Jura et al., (2018) investigated the relationship between maternal nutrition and breast milk composition. However, in this study, mothers used a mix of hand and manual milking methods and the time elapsed since the baby's last feeding, which is another factor that may affect the content of breast milk, was not specified. Due to all these methodological differences, the effect of maternal diet on breast milk composition has not been clarified. These limitations may affect the actual assessment of these relationships. In this context, our study seeks answers to the effect of maternal diet on breast milk composition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hand expressing breast milk | Experimental | Other: Manual breast milk expressionManual milking: Milk was expressed by hand until the milk flow stopped at the mother's breast. While the baby was suckling from one breast, milking was done from the other breast, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - The mother is primigravida
- The mother has given birth naturally
- The mother is only breastfeeding her baby
- The mother is over 19 years old
- The mother's body mass index is within normal values (18.5 to 24.9)
Key exclusion criteria (1 listed)
- The mother wants to quit her job.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual breast milk expressionManual breast milk expression: Milk was expressed by hand until the milk flow stopped at the mother's breast. While the baby was suckling from one breast, milk was expressed from the other breast, and a 10 cc sample was taken from the collected milk and placed in sterile fallopian tubes. The mothers' food records were analyzed for 3 days before the milk sample was taken and on the day the milk sample was taken. | Other | hand expressing breast milk |
Primary outcome
Energy of breast milk as measured by Miris® HMA™ analyzer
Time frame: Postpartum 23rd day
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-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), measured using Miris® Human Milk Analyzer Unit of Measure.
Protein of breast milk as measured by Miris® HMA™ analyzer
Time frame: Postpartum 23rd day
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 Protein content of the mature breast milk-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. "Breast milk protein content (g/100 mL), measured using Miris® Human Milk Analyzer Unit of Measure.
Fat of breast milk as measured by Miris® HMA™ analyzer
Time frame: Postpartum 23rd day
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 content (g/100 mL), measured using Miris® Human Milk Analyzer Unit of Measure.
Carbohydrate of breast milk as measured by Miris® HMA™ analyzer
Time frame: Postpartum 23rd day
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 content of the mature breast milk-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.
Daily maternal energy intake (kcal/day), calculated using BeBiS 8.0
Time frame: postpartum days 20, 21, and 22
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits. Energy intake was calculated in kilocalories and reported as average daily intake. Protein: grams/100 mL Energy: kcal/100 mL 24-Hour Dietary Recall Form
Daily maternal protein intake (gram/day), calculated using BeBiS 8.0
Time frame: postpartum days 20, 21, and 22
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits. Protein: grams/100 mL 24-Hour Dietary Recall Form
Daily maternal fat intake (gram/day), calculated using BeBiS 8.0
Time frame: postpartum days 20, 21, and 22
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits. Fat: grams/100 mL 24-Hour Dietary Recall Form
Daily maternal Carbohydrate intake (gram/day), calculated using BeBiS 8.0
Time frame: postpartum days 20, 21, and 22
Maternal food intake was assessed using the 24-Hour Food Consumption Record form. Data were analyzed using the Nutrition Information System (BeBiS 8.0), a software program adapted to Turkish dietary habits. Carbohydrate : grams/100 mL 24-Hour Dietary Recall Form
4 secondary outcomes
The correlation between maternal dietary intake protein and protein content of breast milk
Time frame: Between matched maternal-milk pairs after the 23rd day postpartum
The correlation between maternal dietary intake energy and energy content of breast milk
Time frame: Between matched maternal-milk pairs after the 23rd day postpartum
The correlation between maternal dietary intake fat and fat content of breast milk
Time frame: Between matched maternal-milk pairs after the 23rd day postpartum
The correlation between maternal dietary intake Carbohydrate and Carbohydrate content of breast milk
Time frame: Between matched maternal-milk pairs after the 23rd day postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No. THE STUDY MAY BE PUBLISHED AFTER IT IS PUBLISHED
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hülya Karataş, Professor study director
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual breast milk expression in people with Breastmilk and Breastmilk Expression, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy of breast milk as measured by Miris® HMA™ analyzer (time frame: Postpartum 23rd day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.