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

NCT ID: NCT06787963

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-02

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Birthweight Infant Preterm Very Low Birth Weight Preterms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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30 extremely low birth weight

extremely low birth weight (\< 1000 g)

No interventions assigned to this group

30 very low birth weight

very low birth weight (1000-1499g)

No interventions assigned to this group

30 low birth weight

low birth weight (1500-2499g)

No interventions assigned to this group

30 adequate birth weight

adequate birth weight (2500-3999g)

No interventions assigned to this group

30 high birth weight

high birth weight (4000g or \>)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy mothers
* With monitored pregnancies within the care area of the Reina Sofía University Hospital in Córdoba
* With newborns expected to be exclusively breastfed until 4 months

Exclusion Criteria

* Mothers whose newborns have any of the following conditions: congenital malformation, chromosomal abnormality, hypoxia-ischemia, gastroschisis, polycythemia, hypoglycemia, sepsis, blood incompatibility
* Pathological pregnancy, pregnancy by in vitro fertilization, or multiple pregnancies
* With no plan to exclusively breastfeed until 4 months
* Under medical treatment
* Have a drug addiction
* Refuse informed consent
* Have had previous breast surgery
* Live outside the metropolitan area
Minimum Eligible Age

0 Days

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role collaborator

Universidad de Córdoba

OTHER

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Maimonides Biomedical Research Institute of Cordoba (IMIBIC)

Locations

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Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Site Status RECRUITING

Maimonides Biomedical Research Institute of Cordoba (IMIBIC)

Córdoba, Córdoba, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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

Role: CONTACT

+34957736467

Ángel Gil, Professor

Role: CONTACT

Facility Contacts

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Mercedes Gil Campos, MD, Ph.D

Role: primary

+34957736467

Mercedes Gil Campos, MD, Ph.D

Role: primary

+34957213745

Other Identifiers

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PROTEOM-MILK

Identifier Type: -

Identifier Source: org_study_id

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