Actively Recruiting
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
Eligibility Criteria
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
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
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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