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

NCT ID: NCT07036094

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2025-02-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

hand expressing breast milk

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.

Group Type: EXPERIMENTAL

Manual breast milk expression

Intervention Type: 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.

Interventions

Manual breast milk expression

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• - 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)

Exclusion Criteria

• The mother wants to quit her job.

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Health Institutes of Turkey

OTHER_GOV

Sponsor Role: collaborator

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hülya Karataş, Professor

Role: STUDY_DIRECTOR

Harran University

Locations

Harran University

Sanliurfa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Breast Milk Composition

Identifier Type: -

Identifier Source: org_study_id