Low Birthweight InfantPROTEOM-MILKNCT06787963
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
An observational study of Low Birthweight Infant and Preterm, run by Maimónides Biomedical Research Institute of Córdoba at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 120 daysHealthy volunteers can take part
- Conditions the study is for
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- How many people
- 150 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Dec 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 120 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Five groups of breastfeeding mothers: Group 1 (n=30) - with neonates of extremely low birth weight; Group 2 (n=30) - with neonates of very low birth weight; Group 3 (n=30) - with neonates of low birth weight; Group 4 (n=30) - with neonates of adequate birth weight; Group 5 (n=30) - with neonates of high birth weight. Additionally, gestational age will be considered to achieve a homogeneous distribution of the groups according to this condition.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ángel Gil, Professor contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004
Mercedes Gil Campos, MD, Ph.D, +34957736467, mercedes_gil_campos@yahoo.es
- Recruiting
Maimonides Biomedical Research Institute of Cordoba (IMIBIC)
Córdoba, Córdoba, 14004
Mercedes Gil Campos, MD, Ph.D, +34957213745, mercedes_gil_campos@yahoo.es
About this study
Official title: Quantitative Proteomic Analysis of Minor Whey Proteins and Peptides of Human Milk Across Five Neonatal Groups Classified by Birth Weight During the Three Stages of Lactation
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.
- Keywords
- low birth weight, prematurity, gestational age, human milk, bioactive peptides, proteomics, lactation, whey protein
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 30 extremely low birth weight | extremely low birth weight (< 1000 g) | |
| 30 very low birth weight | very low birth weight (1000-1499g) | |
| 30 low birth weight | low birth weight (1500-2499g) | |
| 30 adequate birth weight | adequate birth weight (2500-3999g) | |
| 30 high birth weight | high birth weight (4000g or >) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minor whey proteins: Lysozyme
Concentration of lysozyme in ng/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Minor whey proteins: Lactoferrin
Concentration of lactoferrin in mg/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Minor whey proteins: Bile salt-dependent lipase (BSDL)
Concentration of bile salt-dependent lipase (BSDL) in µg/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Minor whey proteins: Lactoperoxidase
Concentration of lactoperoxidase in ng/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Minor whey proteins: Alpha-1-antitrypsin
Concentration of alpha-1-antitrypsin in ng/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Proteome
Protein signatures will be assessed through a proteomic analysis using nano-liquid chromatography (nESI-MS/MS). The analysis will be followed by bioinformatic analysis with dedicated software to analyze and achieve the relative quantification of differential proteins. A specific database representing the human proteome, updated in the UNIPROT repository, will be used. The results will be compared against the protein databases available in international platforms such as SWISS-Prot, NCBI, EBI, and TrEMBL. The results are typically expressed in units or formats that reflect the relative abundance or quantitative values of proteins or peptides, such as spectral counts, percentage and µg/ml.
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Free peptides, primarily derived from β-casein
Free peptides will be expressed in counts per peptide. Human milk samples will undergo trypsin digestion prior to analysis by liquid chromatography-mass spectrometry (LC-MS).
Measured: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Secondary outcomes (2)
Muscular ecography
Muscle thickness will be measured using a Phillips HD ultrasound equipment, with a high-frequency linear probe (7.5 MHz - 15 MHz), in B-mode. The thickness (expressed in mm) of the right quadriceps muscle and subcutaneous tissue will be measured, taken at the midpoint between the greater trochanter and tibial plateau: one anteroposterior in longitudinal section, another anteroposterior in transverse plane, and another perpendicular to the latter in the same plane.
Measured: After birth - Time 1: at 48 hours,Time 2: at 5-14 days, Time 3: at 100-120 days
Transfontanellar ecography
Brain structure and anatomy will be measured using a convex probe with a frequency range of (3.5 - 7 MHz) in B-mode. Longitudinal and transverse sections will be measured, and the thickness of the frontal cortex and the maximum thickness of the corpus callosum will be measured in millimeters (mm).
Measured: After birth - Time 1: at 48 hours,Time 2: at 5-14 days, Time 3: at 100-120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start2 Dec 2024
- Primary completionJan 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birthweight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Universidad de Granada, Universidad de Córdoba
- Responsible party
- Sponsor
- Investigators
- José Luis Gómez-Chaparro Moreno, MD, Ph.D, Principal investigator, Maimonides Biomedical Research Institute of Cordoba (IMIBIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787963
- Sponsor's protocol ID
- PROTEOM-MILK
- Acronym
- PROTEOM-MILK
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed in this study are not publicly available due to data regulations and ethical considerations. Participants consented to the use of their data exclusively by the original team of investigators, ensuring their privacy and adherence to consent agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Proteomic Analysis of Minor Whey Proteins and Peptides of Human Milk Across Five Neonatal Groups Classified by Birth Weight During the Three Stages of Lactation
- ClinicalTrials.gov ID
- NCT06787963
- Acronym / sponsor ID
- PROTEOM-MILK / PROTEOM-MILK
- Keywords
- low birth weight, prematurity, gestational age, human milk, bioactive peptides, proteomics, lactation, whey protein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Universidad de Granada, Universidad de Córdoba
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 30 extremely low birth weight | – | –extremely low birth weight (< 1000 g) |
| 30 very low birth weight | – | –very low birth weight (1000-1499g) |
| 30 low birth weight | – | –low birth weight (1500-2499g) |
| 30 adequate birth weight | – | –adequate birth weight (2500-3999g) |
| 30 high birth weight | – | –high birth weight (4000g or >) |
Who may qualify
- Ages
- 0 to 120 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Five groups of breastfeeding mothers: Group 1 (n=30) - with neonates of extremely low birth weight; Group 2 (n=30) - with neonates of very low birth weight; Group 3 (n=30) - with neonates of low birth weight; Group 4 (n=30) - with neonates of adequate birth weight; Group 5 (n=30) - with neonates of high birth weight. Additionally, gestational age will be considered to achieve a homogeneous distribution of the groups according to this condition.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minor whey proteins: Lysozyme
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Concentration of lysozyme in ng/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Minor whey proteins: Lactoferrin
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Concentration of lactoferrin in mg/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Minor whey proteins: Bile salt-dependent lipase (BSDL)
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Concentration of bile salt-dependent lipase (BSDL) in µg/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Minor whey proteins: Lactoperoxidase
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Concentration of lactoperoxidase in ng/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Minor whey proteins: Alpha-1-antitrypsin
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Concentration of alpha-1-antitrypsin in ng/ml will be measured using immunoassays (Enzyme-Linked ImmunoSorbent Assay).
Proteome
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Protein signatures will be assessed through a proteomic analysis using nano-liquid chromatography (nESI-MS/MS). The analysis will be followed by bioinformatic analysis with dedicated software to analyze and achieve the relative quantification of differential proteins. A specific database representing the human proteome, updated in the UNIPROT repository, will be used. The results will be compared against the protein databases available in international platforms such as SWISS-Prot, NCBI, EBI, and TrEMBL. The results are typically expressed in units or formats that reflect the relative abundance or quantitative values of proteins or peptides, such as spectral counts, percentage and µg/ml.
Free peptides, primarily derived from β-casein
Time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)
Free peptides will be expressed in counts per peptide. Human milk samples will undergo trypsin digestion prior to analysis by liquid chromatography-mass spectrometry (LC-MS).
2 secondary outcomes
Muscular ecography
Time frame: After birth - Time 1: at 48 hours,Time 2: at 5-14 days, Time 3: at 100-120 days
Transfontanellar ecography
Time frame: After birth - Time 1: at 48 hours,Time 2: at 5-14 days, Time 3: at 100-120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No. The datasets generated and analyzed in this study are not publicly available due to data regulations and ethical considerations. Participants consented to the use of their data exclusively by the original team of investigators, ensuring their privacy and adherence to consent agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ángel Gil, Professor contact
José Luis Gómez-Chaparro Moreno, MD, Ph.D principal investigator
Maimonides Biomedical Research Institute of Cordoba (IMIBIC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Birthweight Infant and Preterm, run by Maimónides Biomedical Research Institute of Córdoba at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Luis Gómez-Chaparro Moreno, MD, Ph.D (+34957736467, drgomezchaparro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minor whey proteins: Lysozyme (time frame: Human Milk collection after birth - Time 1: at 48 hours (colostrum),Time 2: at 5-14 days (transitional milk), Time 3: at 100-120 days (mature milk)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.