Immunomodulatory Effects of Zinc and Selenium-Enriched Lentinula edodes Extract: Biochemical Characterization and...

The primary hypothesis of the study was that zinc and selenium supplementation through fortified cookies would enhance the immune response and improve clinical outcomes in tuberculosis patients. For this purpose, a single-blind randomized control trial was carried out to determine the effect of zinc and selenium on the immunomodulatory parameters of tuberculosis, approved by the Ethics Committee of the University of Lahore, Pakistan. In the first phase, the proximate and minerals profile of shiitake mushroom was analyzed, and functional cookies were developed fortified with zinc and selenium. In the second phase, 120 tuberculosis patients were divided into four groups (T0, T1, T2, and T3) to assess the impact of supplementation on anthropometric, microbiological, and hematological parameters. Meanwhile, results were statistically examined through one-way ANOVA followed by Duncan's Multiple Range Test and showed significant differences (p ≤ 0.05) among treatment groups. In comparison to controls, patients who received Zn and Se-enriched cookies (T2 and T3) reported significant increases in BMI, hemoglobin, and decreases in CRP and ESR. Additionally, Principal component analysis (PCA) and heat map visualization were generated using R Studio (Version 4.2.2) to identify patterns and correlations among treatments. During tuberculosis infection, those improvements were associated with the antioxidant and immunomodulatory functions of zinc in macrophage activation and selenium-dependent glutathione peroxidase activity, which are involved in the regulation of oxidative stress. Thus, the results showed that the therapeutic effect of dosage on anthropometric, microbiological, and hematological measurements showed a significant result, indicating that zinc and selenium may help to modulate the immunological response, and potentially improve the body's ability to resist tuberculosis. Trial Registration: ClinicalTrials.gov (Identifier: NCT07180329).