Determinants of the Nutritional Composition of Donor Human Milk

Study of Determinants of the Nutritional Composition of Donor Human Milk

Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment. In special circumstances, such as prematurity or illness, breast milk is not always available, and donor human milk (DHM) is an option. Some studies have reported growth retardation in babies fed DHM, probably due to the less adequate nutritional composition. There are several factors that contribute to changes in its nutritional composition. Among the various factors, the following are worth highlighting: wide variety of donors with different characteristics (e.g. gestational age, lactation phase, diet); inconsistency of the collection method; impact of milk processing, i.e. the pasteurization process.

As the Human Milk Bank of North (BLHN - Banco de Leite Humano do Norte) is the first in the North region of Portugal, and there are few studies developed in this area in Portugal, the present project aims to study the influence of the following factors on the composition of the DHM:

• Pasteurization process;
• Dietary habits of donors;
• Body composition of donors.

Study Overview

• Status: Not yet recruiting
• Conditions: Human Milk Nutrition

Detailed Description

Study design and sampling: observational study with a cross-sectional and prospective design. The sample will consist of mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.

Data collection: in order to meet the objectives of the research project, a questionnaire was drawn up for the participants, to be administered on paper, in an interview format, in the context of an outpatient consultation.

The questionnaire lasts around 20 minutes and consists of sociodemographic information (age, household composition, marital status, nationality, educational qualifications, profession); personal history (pathologies, number of pregnancies and births, date of last birth, gender, age, birth weight and length of the newborn, presence of gestational diabetes, hypertension in pregnancy, pre-eclampsia, term or pre-term birth, twin pregnancy); anthropometric data and body composition of the donor; food frequency questionnaire; physical activity; nutritional composition of the donated milk before and after processing (pasteurization).

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Janete Santos, PhD; Phone Number: +351 225 513 600; Email: investigaclinica@med.up.pt
• Study Contact Backup: Name: Marta Rola; Phone Number: +351 934742214; Email: marta.rola@chsj.min-saude.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitário São João (CHUSJ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Human milk donors from BLHN

Description

Inclusion Criteria:

• Human milk donors at BLHN
• Informed consent of the participant

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Human milk donor; Mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy of donated human milk	Determination of the energy composition of the donated human milk (kcal/100mL).	At baseline before pasteurization; at baseline after pasteurization.
Total protein levels of donated human milk	Determination of the total protein levels of the donated human milk (g/100mL).	At baseline before pasteurization; at baseline after pasteurization.
True protein levels of donated human milk	Determination of true protein levels of the donated human milk (g/100mL).	At baseline before pasteurization; at baseline after pasteurization.
Fat levels of donated human milk	Determination of fat levels of the donated human milk (g/100mL).	At baseline before pasteurization; at baseline after pasteurization.
Carbohydrates levels of donated human milk	Determination of carbohydrates levels of donated human milk (g/100mL).	At baseline before pasteurization; at baseline after pasteurization.
Body mass index of the donor	Height (m) and weight (kg) at the beginning and at the end of pregnancy of the donor to calculate pre-pregnancy body mass index (BMI) (kg/m^2) and the post-pregnancy BMI (kg/m^2).	At baseline
Gestational weight gain of the donor	Gestational weight gain (kg) by the donor.	At baseline
Waist circunference of the donor.	Waist circunference (cm) of the donor.	At baseline
Hip circunference of the donor	Hip circunference (cm) of the donor.	At baseline
Assessment of the donors' eating habits	The dietary habits of the previous year will be assessed using a semiquantitative food frequency questionnaire (FFQ) validated for the Portuguese adult population.	At baseline

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Faculdade de Medicina da Universidade do Porto - CINTESIS; Centro Hospitalar De São João, E.P.E.; Banco de Leite Humano do Norte; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto (FCNAUP)

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Donor human milk; Human milk nutrition
• Other Study ID Numbers: BLHN/ Pediatric Nutrition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No