Actively Recruiting

Age: 0Days - 120Days
All Genders
Healthy Volunteers
NCT06787963

Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages

Led by Maimónides Biomedical Research Institute of Córdoba · Updated on 2025-01-22

150

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

M

Maimónides Biomedical Research Institute of Córdoba

Lead Sponsor

H

Hospital Universitario Reina Sofia de Cordoba

Collaborating Sponsor

AI-Summary

What this Trial Is About

Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants. HM contains a wide variety of minor whey proteins and peptides with important bioactive functions, many of which are still unknown. Proteomics allows for the study of biological samples with inherently complex protein mixtures. Proteins are essential for the development of living organisms, both in quantitative and qualitative terms. The combination of proteomic techniques currently enables the study of protein variability and minor peptides in HM across different lactation stages and allows for differential quantification according to gestational age and birth weight. However, studies on the human milk serum proteome during these stages are limited. The aim is to explore the minor whey proteins and peptides in human milk through a longitudinal analysis of five groups of breastfeeding mothers (with 30 extremely low birth weight newborns, 30 very low birth weight newborns, 30 low birth weight newborns, 30 adequate birth weight newborns, and 30 high birth weight newborns). Gestational age will also be considered to ensure homogeneous group distribution according to this condition. HM samples will be collected from each mother during three lactation periods after birth: within the first 48 hours (colostrum), at 5-14 days (transitional milk), and at 100-120 days (mature milk) for the five birth weight groups. In these neonatal/infant groups, minor proteins from whey fraction and peptides will be separated, quantified, and identified using label-free proteomic techniques. This study aims to expand our understanding of the minor proteins and peptides in human milk and their bioactive roles in neonatal health. By examining these components across different birth weight groups and lactation stages, the research will offer insights into how protein and peptide profiles vary by gestational age and birth weight, potentially influencing neonatal development. The findings from this proteomic analysis could not only demonstrate the complexity of human milk composition but also contribute to targeted nutritional support for preterm or low-birth-weight infants, customizing protein supplementation in HM banks and therefore enhancing their growth and developmental outcomes.

CONDITIONS

Official Title

Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages

Who Can Participate

Age: 0Days - 120Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy mothers
  • Monitored pregnancies within the care area of Reina Sofía University Hospital in Córdoba
  • Newborns expected to be exclusively breastfed until 4 months
Not Eligible

You will not qualify if you...

  • Newborns with congenital malformation, chromosomal abnormality, hypoxia-ischemia, gastroschisis, polycythemia, hypoglycemia, sepsis, or blood incompatibility
  • Pathological pregnancy, pregnancy by in vitro fertilization, or multiple pregnancies
  • No plan to exclusively breastfeed until 4 months
  • Under medical treatment
  • Drug addiction
  • Refuse informed consent
  • Previous breast surgery
  • Living outside the metropolitan area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain, 14004

Actively Recruiting

2

Maimonides Biomedical Research Institute of Cordoba (IMIBIC)

Córdoba, Córdoba, Spain, 14004

Actively Recruiting

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Research Team

J

José Luis Gómez-Chaparro Moreno, MD, Ph.D

CONTACT

Á

Ángel Gil, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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