Relationship Between Nutritional Consumption of Breastfeeding Mothers and Breast Milk Composition During Lactation

NCT07036094 | Completed

• 1 other identifier: Breast Milk Composition
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breastmilk; Breastmilk Expression; Maternal Nutrition

Keywords

human milk; maternal nutrition; lactation; breastmilk

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  postpartum days 20, 21, and 22

Secondary Outcomes (4)

• The correlation between maternal dietary intake protein and protein content of breast milk

  Between matched maternal-milk pairs after the 23rd day postpartum

• The correlation between maternal dietary intake energy and energy content of breast milk

  Between matched maternal-milk pairs after the 23rd day postpartum

• The correlation between maternal dietary intake fat and fat content of breast milk

  Between matched maternal-milk pairs after the 23rd day postpartum

• The correlation between maternal dietary intake Carbohydrate and Carbohydrate content of breast milk

  Between matched maternal-milk pairs after the 23rd day postpartum

Study Arms (1)

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.

Other: Manual breast milk expression

Interventions

Manual breast milk expression OTHER

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.

hand expressing breast milk

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: It should be done with breastfeeding mothers after birth. Breast milk has been analyzed.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• The mother wants to quit her job.

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; Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Hülya Karataş, Professor

  Harran University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 25, 2025
• Study Start: August 30, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)