An interventional study of Myrin P Fort and Zn + Se supplemented cookies in Immunomodulatory Drugs and Tuberculosis, sponsored by University of Lahore. Completed at 1 site in Pakistan. Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by University of Lahore · Not applicable, Interventional, and Supportive care
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 \& T3) to assess the impact of supplementation on anthropometric, microbiological, and hematological parameters. Meanwhile, results were statistically examined through Principal component analysis and a heat map of the attributes under research were generated using R-studio (Version 4.2.2). However, results explained that the therapeutic effect of dosage on anthropometric, microbiological, and hematological measurements showed a significant result (p≤0.05), indicating that zinc and selenium may help to modulate the immunological response, and potentially improving the body's ability to resist tuberculosis.
2. Materials and methods 2.1. Procurement of raw materials Shiitake was procured from the departmental store of Lahore and placed in a sealed bag (Zip bag). All the research work was performed at the University of Lahore's Institute of Food Science and Technology
2.2. Fortification of Zn and Se in the rice flour cookies Cookies were made with rice flour samples supplemented with Zn and Se extracted from shiitake mushroom, at concentrations of 100, 150, and 200 mg/kg of cookie dough, according to the usual process outlined by AACC. Butter, sugar, salt, baking powder, egg, ghee and water were used as common ingredients in all treatments, while Zn, and Se extracted from shiitake powder were used as variable ingredients according to the treatments plan given in ST 1. All ingredients were weighed precisely and mixed homogeneously in laboratory mixer bowl for 10 minutes for each treatment group (T0, T1, T2 and T3). After the homogenous mixing, a resting period of 10 to 15 minutes was applied. The dough was converted into a 5mm thick sheet which was cut into cookies using suitable molds. Baking was accomplished at 170°C for 12 to 15 minutes followed by cooling at room temperature. After cooling, cookies were packed in propylene bags. However, each serving (one cookie) in groups T1, T2, and T3 provided an average of 10 mg:10 µg, 15 mg:15 µg, and 20 mg:20 µg of Zn and Se, respectively, as verified by formulation and batch testing. All batches were processed under standardized conditions to ensure ingredient homogeneity and batch to batch uniformity.
Anthropometric measurements, Microbiological and Hematological Parameters were measured 2.4. Statistical Analysis All resulting data were analyzed statistically to test the significance level (p≤0.05) via the completely randomized design (CRD) by using analytical software statistix (version 8.1).
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 90 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
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Exclusion Criteria
Patients took Myrin P Fort
Dietary Supplement: Myrin P Fort
patients took Zn + Se supplemented cookies
Dietary Supplement: Zn + Se + Myrin P Fort
Patients took Zn + Se \+ Myrin P Fort
Dietary Supplement: Zn + Se supplemented cookies
Patient took Myrin P Fort
patients took Zn + Se supplemented cookies
patients took Zn + Se \+ Myrin P Fort
Anthropometric measurements
Body Mass Index was measured. The formula for Body Mass Index (BMI) is: kg/m\^2.
Time frame: 5 months
Determination of MAC, MAMC, and TSF
The anthropometric measurements of the patients were assessed, including Mid-Arm Circumference (MAC, cm), Mid-Arm Muscle Circumference (MAMC, cm), and Triceps Skinfold Thickness (TSF, mm). These parameters were measured to evaluate the nutritional and muscle status of the patients
Time frame: 5 months
Hematological analysis
Hematological analyses were performed, including hemoglobin concentration (g/dL)
Time frame: 5 months
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Lahore