Actively Recruiting

Age: 0Days - 120Days
All Genders
Healthy Volunteers
ID06787963

Proteomic Analysis of Minor Whey Proteins and Peptides in Human Milk Across Five Birth Weight Groups During Three 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 is considered the best source of nutrition for newborns, supporting their growth and development. This research aims to explore the minor whey proteins and peptides found in human milk, which have important bioactive functions that are not yet fully understood. The study focuses on five groups of breastfeeding mothers classified by the birth weight of their newborns, ranging from extremely low to high birth weight, while also considering gestational age to ensure balanced groups. It seeks to better understand how protein and peptide profiles in human milk vary across these groups and different stages of lactation. The study involves collecting human milk samples from each mother at three specific times after birth: within the first 48 hours (colostrum), between 5 and 14 days (transitional milk), and between 100 and 120 days (mature milk). These samples will be analyzed using advanced proteomic techniques to separate, identify, and quantify minor whey proteins and peptides. The research examines key proteins such as lysozyme, lactoferrin, bile salt-dependent lipase, lactoperoxidase, alpha-1-antitrypsin, and others to understand their presence and changes over time. Participants will provide milk samples during the three lactation periods. Researchers will measure various proteins and peptides in these samples to observe their variations by birth weight and gestational age. The study aims to expand knowledge about the complexity of human milk and its biological roles in neonatal health. Results may help improve nutritional support for preterm or low-birth-weight infants by tailoring protein supplementation in human milk banks, potentially enhancing infant growth and development 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

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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

Á

Ángel Gil, Professor

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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