NCT06787963 Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
| NCT ID | NCT06787963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba |
| Condition | Low Birthweight Infant |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-12-02 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
José Luis Gómez-Chaparro Moreno, MD, Ph.D
PRINCIPAL INVESTIGATOR
Maimonides Biomedical Research Institute of Cordoba (IMIBIC)
Frequently Asked Questions
Who can join the NCT06787963 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 120 Days, studying Low Birthweight Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06787963 currently recruiting?
Yes, NCT06787963 is actively recruiting participants. Contact the research team at drgomezchaparro@gmail.com for enrollment information.
Where is the NCT06787963 trial being conducted?
This trial is being conducted at Córdoba, Spain, Córdoba, Spain.
Who is sponsoring the NCT06787963 clinical trial?
NCT06787963 is sponsored by Maimónides Biomedical Research Institute of Córdoba. The principal investigator is José Luis Gómez-Chaparro Moreno, MD, Ph.D at Maimonides Biomedical Research Institute of Cordoba (IMIBIC). The trial plans to enroll 150 participants.