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

NCT06787963 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-01-22

No results posted yet for this study

Summary

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

  • Low Birthweight Infant
  • Preterm
  • Very Low Birth Weight Preterms

Sponsors & Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

    collaborator OTHER_GOV
  • Universidad de Granada

    collaborator OTHER
  • Universidad de Córdoba

    collaborator OTHER
  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • José Luis Gómez-Chaparro Moreno, MD, Ph.D · Maimonides Biomedical Research Institute of Cordoba (IMIBIC)

Eligibility

Min Age
0 Days
Max Age
120 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2026-01-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06787963 on ClinicalTrials.gov