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Lactogenic bio-actives as nutraceutical agents: Exploring the clinical potential of human breast milk
*Corresponding author: Rehan Haider Naqvi, Department of Pharmacy, University of Karachi, F3 Falak Numa Apartment, Block 14 Gulshan-e-Iqbal, Karachi, Pakistan. rehan_haider64@yahoo.com
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Received: ,
Accepted: ,
How to cite this article: Naqvi RH, Khanzada ZA. Lactogenic bio-actives as nutraceutical agents: Exploring the clinical potential of human breast milk. South Asian J Health Sci. doi: 10.25259/SAJHS_46_2025
Abstract
Human breast milk (HBM) is a complex biological fluid containing a wide range of bioactive compounds, including lactoferrin, human milk oligosaccharides (HMOs), immunoglobulins, cytokines, growth factors, extracellular vesicles, and antioxidant enzymes. These components are well established for their essential role in infant growth and immune development. Increasing scientific interest has focused on the translational potential of these lactogenic bioactive compounds as nutraceutical agents for adult health, particularly in men. Emerging evidence suggests that these bioactive constituents possess immunomodulatory, antimicrobial, anti-inflammatory, metabolic, antioxidant, and regenerative properties that may offer therapeutic benefits beyond infancy. This narrative review evaluates the biochemical mechanisms, physiological pathways, and clinical implications of HBM-derived bioactive compounds in adult male health. Their potential roles in immune regulation, gastrointestinal balance, metabolic syndrome management, wound healing, infection control, and oxidative stress reduction are critically examined. Available adult clinical studies on isolated lactoferrin, HMOs, and milk-derived exosomes are analysed to assess their translational relevance. A conceptual framework is proposed to integrate mechanistic insights with emerging clinical evidence. Ethical considerations, regulatory challenges, and safety aspects associated with donor milk–derived and purified formulations are also discussed. Although promising mechanistic and preliminary clinical data support their nutraceutical potential, further well-designed randomised controlled trials are required to validate efficacy, dosage, and long-term safety in adult populations.
Keywords
Exosomes
Human breast milk
Human milk oligosaccharides
Immunomodulation
Lactoferrin
INTRODUCTION
Human breast milk (HBM) is one of the most biologically complex natural fluids known, containing more than 2,500 bioactive molecules that contribute to immunological protection, metabolic regulation, antimicrobial defence, and tissue development. metabolic regulation, antimicrobial defence, and tissue development. [1,2] These components play a critical role in infant growth and immune system maturation. Key bioactive constituents include lactoferrin, human milk oligosaccharides (HMOs), immunoglobulins, cytokines, growth factors, antioxidant enzymes, and extracellular vesicles [Table 1].[3,4]
| Component | Biological function | Potential therapeutic effect in adult men | Supporting evidence |
|---|---|---|---|
| Lactoferrin | Antimicrobial, anti-inflammatory, and iron regulation | Reduces systemic inflammation; enhances immune defence; supports wound healing | Anti-inflammatory and antimicrobial activity shown in adult clinical trials |
| Human milk oligosaccharides (HMOs) | Prebiotic, anti-adhesive, immune modulation | Improved gut microbiota; reduction in gut inflammation; enhanced metabolic health | HMO supplementation improves adult gut microbiome diversity |
| Immunoglobulin A (IgA) | Mucosal immunity, pathogen neutralisation | Supports gastrointestinal and respiratory protection | Known mucosal immune benefits in adults |
| Epidermal growth factor (EGF) | Tissue regeneration, epithelial repair | Accelerates wound healing; enhances mucosal recovery | EGF is used in adult wound healing therapeutics |
| Transforming growth factor-β (TGF-β) | Immune tolerance, anti- inflammatory | Reduces inflammatory cytokines; supports autoimmune regulation | Anti-inflammatory pathways are well studied |
| Exosomes & miRNAs | Gene regulation, metabolic signalling | Immune modulation; metabolic improvement; cellular regeneration | Milk exosomes are shown to affect adult cells in vitro |
| Antioxidant enzymes (SOD, catalase) | Neutralise oxidative stress | Reduces tissue damage, enhances healing, and protects organs | Antioxidant benefits confirmed in adult nutrition |
| Lysozyme | Antibacterial enzyme | Protects against bacterial infections | Demonstrated antibacterial activity in adult tissues |
| Antimicrobial defence | Enhances antimicrobial barrier in wounds and mucosa | Used in adult oral and wound products |
SOD: Superoxide dismutase, HMO: Human milk oligosaccharides
The components of breast milk exceed their function of providing nutrition for newborns because these elements demonstrate abilities to modulate immune responses, decrease inflammation, and fight infections and control metabolic functions, which could lead to medical applications.[5,6] The development of recombinant biotechnology, together with advanced molecular purification methods, enables researchers to extract specific milk-based bioactive compounds that they can use for the standardized production of nutraceutical products.[4,7,8]
This narrative review synthesises current mechanistic and clinical evidence regarding HBM-derived bioactive compounds as nutraceutical agents in adult men. The review integrates molecular insights, preclinical findings, and available adult human studies while discussing ethical, safety, and regulatory considerations relevant to translational application.
Adult morbidity occurs throughout the globe because chronic inflammatory diseases, metabolic syndrome, and oxidative stress–related disorders and immune dysregulation persist as major health problems. Natural bioactive compounds with multi-targeted mechanisms represent promising adjunct therapeutic strategies.[5] This narrative review synthesizes mechanistic and emerging clinical evidence regarding purified human milk–derived bioactive compounds in adult health.
This narrative review synthesises evidence from peer-reviewed publications indexed in PubMed, Scopus, and Google Scholar. Literature focusing on HBM bioactive components and their potential translational relevance in adult populations was evaluated. Mechanistic studies, preclinical findings, and available adult clinical evidence were integrated to provide a comprehensive overview of potential nutraceutical applications.
METHODOLOGY
The authors conducted this narrative review through systematic literature searches, which they performed in PubMed, Scopus, and Google Scholar databases. The research included peer-reviewed studies that examined human milk bioactive components and their possible use in adult populations. The study conducted a qualitative analysis of mechanistic studies, which included in vitro research and animal testing, and all existing clinical trials conducted with adult participants.
MECHANISTIC INSIGHTS AND TRANSLATIONAL IMPLICATIONS
Lactoferrin
Lactoferrin is an iron-binding glycoprotein with antimicrobial, antiviral, and anti-inflammatory properties.[9,10] It modulates cytokine production and supports innate immune defense mechanisms.[11] Adult supplementation studies have demonstrated reduced inflammatory markers, improved iron metabolism, and enhanced infection resistance.[10]
HMOs
HMOs function as selective prebiotics and immune dulators.[12] They promote beneficial gut microbiota growth and inhibit pathogen adhesion to epithelial surfaces.[13] Clinical studies in adults have reported improved microbiome diversity and gastrointestinal tolerance following HMO supplementation.[14]
Immunoglobulins
Secretory IgA plays a central role in mucosal immune defense by neutralizing pathogens and maintaining immune tolerance.[15] Human milk immunological components contribute to immune modulation and microbial protection.[16]
Growth factors
Epidermal growth factor (EGF) and transforming growth factor-β (TGF-β) are essential for epithelial repair and immune regulation.[17] Anti-inflammatory and tissue-regenerative pathways associated with milk-derived growth factors are well documented.[18]
Milk-derived exosomes and microRNAs
Milk-derived extracellular vesicles contain bioactive microRNAs capable of influencing gene expression and metabolic signaling pathways.[13,19] Experimental studies demonstrate that these exosomes retain biological activity in adult cellular systems.[20]
Immunoglobulins
Secretory IgA functions as the primary defense mechanism for mucosal immune protection through its ability to block pathogens while it helps the body maintain immune system balance.[15] The immunological elements found in human milk function to modulate immune responses while they provide defense against microbial threats.[16]
Growth factors
EGF and TGF-β serve as vital factors that support the process of epithelial tissue restoration while they control various aspects of immune system function.[17] Research has established that milk-derived growth factors activate pathways that promote tissue healing while they suppress inflammation.[18]
Milk-derived exosomes and microRNAs
The extracellular vesicles derived from milk carry active microRNAs, which possess the ability to regulate gene expression and control metabolic signalling networks.[13,19]
The research findings show that these exosomes maintain their biological functions within adult human cell systems.[20]
Results and mechanistic interpretation
The synthesized evidence indicates that human breast milk– derived bioactive compounds exert biological effects through multiple interconnected molecular pathways.[21]
Lactoferrin, TGF-β, and cytokine signalling pathways contribute to anti-inflammatory modulation, while EGF-mediated pathways enhance epithelial regeneration and tissue repair. HMOs support gut microbiota stability and intestinal barrier integrity. Immunoglobulins, lysozyme, and lactoperoxidase provide antimicrobial defense mechanisms. Additionally, antioxidant enzymes reduce oxidative stress and cellular damage. Collectively, these mechanistic interactions suggest potential applications of HBM-derived nutraceutical formulations in immune dysfunction, gastrointestinal disorders, metabolic syndrome, wound healing, and infection control in adult male populations [Figure 1].
- Mechanistic pathways of human breast milk derived nutraceutical bio-actives in adult health. SCFA: Short-chain fatty acids, EGF: Epidermal growth factor, IGF: Insulin-like growth factor.
Antioxidant enzymes
Superoxide dismutase, catalase, and glutathione peroxidase reduce oxidative stress and cellular damage. Their integration into nutraceutical formulations may contribute to protection against inflammation-associated disorders.
The synthesised evidence indicates that HBM–derived bioactive compounds exert biological effects through multiple interconnected molecular pathways. Lactoferrin, TGF-β, and cytokine signalling pathways contribute to anti-inflammatory modulation, while EGF-mediated pathways enhance epithelial regeneration and tissue repair. HMOs support gut microbiota stability and intestinal barrier integrity. Immunoglobulins, lysozyme, and lactoperoxidase provide antimicrobial defence mechanisms. Additionally, antioxidant enzymes reduce oxidative stress and cellular damage. Collectively, these mechanistic interactions suggest potential applications of HBM-derived nutraceutical formulations in immune dysfunction, gastrointestinal disorders, metabolic syndrome, wound healing, and infection control in adult male populations.
The present narrative synthesis integrates mechanistic insights and emerging adult clinical evidence to evaluate the translational potential of HBM–derived bioactives in adult male health. Among the identified components, lactoferrin and HMOs currently possess the strongest clinical support in adult populations. Evidence suggests that lactoferrin contributes to immune regulation, reduction of inflammatory markers, modulation of iron metabolism, and enhanced wound repair. Similarly, HMOs demonstrate prebiotic and barrier-protective functions that may positively influence metabolic and gastrointestinal health.
Growth factors such as EGF and TGF-β, along with milk-derived exosomes and microRNAs, represent promising but still emerging therapeutic avenues. While experimental and preclinical data indicate potential roles in tissue regeneration, immune modulation, and metabolic signalling, robust adult clinical validation remains limited. These components require further investigation to determine bioavailability, pharmacokinetics, dosage standardisation, and long-term safety profiles.
Translational applications also raise important regulatory and ethical considerations. Direct donor milk utilisation for adult therapy is not practical; therefore, recombinant production, synthetic oligosaccharides, and purified bioactive formulations represent more feasible and ethically acceptable approaches. Standardisation of extraction methods and quality control measures will be essential to ensure consistency and safety.
The current adult clinical research demonstrates that lactoferrin stands as the most researched bioactive component among all identified bioactive components. The study established that two different types of studies proved their power to fight inflammation and germs.
Research has shown that HMOs can function as prebiotics while preserving protective elements in adults. The microbiota composition of their gut system affects their body processes, which lead to metabolic changes and inflammation in their entire system.[22]
Recent research shows that milk-derived exosomes and growth factors can affect gene expression, along with their ability to control immune response and support tissue healing. The available evidence primarily comes from studies conducted on either preclinical models or research centered on infants.
Researchers should use purified recombinant proteins or synthetic bioactive compounds for their translational research work instead of using donor milk as their research material. Researchers must consider both ethical sourcing practices and regulatory oversight requirements.
Limitations
Most available data originate from infant studies, animal models, or in vitro experiments. Differences in immune maturation, metabolic pathways, hormonal regulation, and gut microbiota composition between infants and adults necessitate cautious extrapolation. Large-scale randomised clinical trials in adult male populations remain limited.[23]
Future directions
Future research should prioritise well-designed randomised controlled trials in adult populations, standardised bioactive extraction and purification protocols, dose-response modelling, and long-term safety evaluation to support clinical translation.
CONCLUSION
Standardised and purified HBM–derived bio-actives demonstrate promising nutraceutical potential for immune modulation, gastrointestinal support, metabolic regulation, oxidative stress reduction, and tissue regeneration in adult men. While emerging evidence is encouraging, robust clinical validation remains essential before widespread therapeutic application.
Acknowledgement:
The authors would like to express their sincere gratitude to Dr. Naweed Imam Syed, Professor, Department of Cell Biology, University of Calgary, for his valuable guidance and academic support during the conceptual development of this work.
Authors’ contributions:
RH: Conceptualization, literature review, manuscript drafting, and final approval; ZA: Scientific review, manuscript editing, and critical revision.
Ethical approval:
Institutional Review Board approval is not required.
Declaration of patient consent:
Patient's consent not required as there are no patients in this study.
Conflicts of interest:
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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