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Determinants of the Nutritional Composition of Donor Human Milk

Study of Determinants of the Nutritional Composition of Donor Human Milk

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06904924
Enrollment
80
Registered
2025-04-01
Start date
2025-05-31
Completion date
2028-06-30
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Milk Nutrition

Keywords

Donor human milk, Human milk nutrition

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.

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).

Interventions

None listed

Sponsors

Banco de Leite Humano do Norte
CollaboratorUNKNOWN
Centro Hospitalar De São João, E.P.E.
CollaboratorOTHER
Faculdade de Medicina da Universidade do Porto - CINTESIS
CollaboratorUNKNOWN
Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto (FCNAUP)
CollaboratorUNKNOWN
Universidade do Porto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Energy of donated human milkAt baseline before pasteurization; at baseline after pasteurization.Determination of the energy composition of the donated human milk (kcal/100mL).
Total protein levels of donated human milkAt baseline before pasteurization; at baseline after pasteurization.Determination of the total protein levels of the donated human milk (g/100mL).
True protein levels of donated human milkAt baseline before pasteurization; at baseline after pasteurization.Determination of true protein levels of the donated human milk (g/100mL).
Fat levels of donated human milkAt baseline before pasteurization; at baseline after pasteurization.Determination of fat levels of the donated human milk (g/100mL).
Carbohydrates levels of donated human milkAt baseline before pasteurization; at baseline after pasteurization.Determination of carbohydrates levels of donated human milk (g/100mL).
Body mass index of the donorAt baselineHeight (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).
Gestational weight gain of the donorAt baselineGestational weight gain (kg) by the donor.
Waist circunference of the donor.At baselineWaist circunference (cm) of the donor.
Hip circunference of the donorAt baselineHip circunference (cm) of the donor.
Assessment of the donors' eating habitsAt baselineThe dietary habits of the previous year will be assessed using a semiquantitative food frequency questionnaire (FFQ) validated for the Portuguese adult population.

Countries

Portugal

Contacts

Primary ContactMarta Rola
marta.rola@chsj.min-saude.pt+351 934742214
Backup ContactJanete Santos, PhD
investigaclinica@med.up.pt+351 225 513 600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026