Determinants of the Nutritional Composition of Donor Human Milk

NCT06904924 | Not Yet Recruiting

• 1 other identifier: BLHN/ Pediatric Nutrition
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Milk Nutrition

Keywords

Donor human milk; Human milk nutrition

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Human milk donor

Mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Human milk donors from BLHN

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Centro Hospitalar Universitário São João (CHUSJ)

Porto, 4200-319, Portugal

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Donor's human milk (DHM).

Central Study Contacts

Marta Rola

CONTACT

+351 934742214; marta.rola@chsj.min-saude.pt

Janete Santos, PhD

CONTACT

+351 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 1, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

PT (1)