Immunomodulatory DrugsNCT07180329
Zinc and Selenium Bioactivity
A study testing Myrin P Fort, Zn + Se supplemented cookies and Zn + Se + Myrin P Fort in people with Immunomodulatory Drugs and Tuberculosis, run by University of Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Immunomodulatory Drugs, Tuberculosis
- What is being tested?
- Myrin P Fort, Zn + Se supplemented cookies and Zn + Se + Myrin P Fort
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 30-55 years.
- Confirmed diagnosis of pulmonary tuberculosis (Pul-TB) with positive acid-fast bacilli (AFB) in sputum samples.
Who cannot join
- Patients diagnosed with extra-pulmonary TB.
- Patients who had been on anti-TB therapy for more than 2 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Zinc and Selenium Bioactivity in Modulating Immune Parameters in Tuberculosis
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.
Read the detailed description
- 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).
- Conditions
- Immunomodulatory Drugs, Tuberculosis
- Being tested
- Myrin P Fort, Zn + Se supplemented cookies, Zn + Se + Myrin P Fort
- Keywords
- Nutrition, tuberculosis, immunomodulatory, mushrooms, fortified
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myrin P FortDietary supplement
Patient took Myrin P Fort
Zn + Se supplemented cookiesDietary supplement
patients took Zn + Se supplemented cookies
Zn + Se + Myrin P FortDietary supplement
patients took Zn + Se
+ Myrin P Fort
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients took Myrin P Fort Receives: Dietary Supplement: Myrin P Fort |
| Zn + Se supplemented cookies | Experimental | patients took Zn + Se supplemented cookies Receives: Dietary Supplement: Zn + Se + Myrin P Fort |
| Zn + Se + Myrin P Fort | Experimental | Patients took Zn + Se
+ Myrin P Fort Receives: Dietary Supplement: Zn + Se supplemented cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
Body Mass Index was measured. The formula for Body Mass Index (BMI) is: kg/m^2.
Measured: 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
Measured: 5 months
Secondary outcomes (1)
Hematological analysis
Hematological analyses were performed, including hemoglobin concentration (g/dL)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Feb 2023
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunomodulatory DrugsStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Noreen, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180329
- Sponsor's protocol ID
- REC-UOL-FAHS/906/2022
- Status last verified
- Feb 2023
- First submitted
- 29 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mughal H, Tufail T, Ain HBU, Rasheed A, Alum EU. Immunomodulatory Effects of Zinc and Selenium-Enriched Lentinula edodes Extract: Biochemical Characterization and Bioactivity Relevant to Tuberculosis. Food Sci Nutr. 2026 Apr 8;14(4):e71736. doi: 10.1002/fsn3.71736. eCollection 2026 Apr.
PubMed 41971609
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Zinc and Selenium Bioactivity in Modulating Immune Parameters in Tuberculosis
- ClinicalTrials.gov ID
- NCT07180329
- Acronym / sponsor ID
- REC-UOL-FAHS/906/2022
- Conditions
- Immunomodulatory Drugs, Tuberculosis
- Keywords
- Nutrition, tuberculosis, immunomodulatory, mushrooms, fortified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 18 Sep 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.
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.
Detailed description
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Myrin P FortPatients took Myrin P Fort |
| Zn + Se supplemented cookies | Experimental | Dietary Supplement: Zn + Se + Myrin P Fortpatients took Zn + Se supplemented cookies |
| Zn + Se + Myrin P Fort | Experimental | Dietary Supplement: Zn + Se supplemented cookiesPatients took Zn + Se + Myrin P Fort |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 30-55 years.
- Confirmed diagnosis of pulmonary tuberculosis (Pul-TB) with positive acid-fast bacilli (AFB) in sputum samples.
Key exclusion criteria (2 listed)
- Patients diagnosed with extra-pulmonary TB.
- Patients who had been on anti-TB therapy for more than 2 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myrin P FortPatient took Myrin P Fort | Dietary supplement | Control group |
| Zn + Se supplemented cookiespatients took Zn + Se supplemented cookies | Dietary supplement | Zn + Se + Myrin P Fort |
| Zn + Se + Myrin P Fortpatients took Zn + Se + Myrin P Fort | Dietary supplement | Zn + Se supplemented cookies |
Primary outcome
Anthropometric measurements
Time frame: 5 months
Body Mass Index was measured. The formula for Body Mass Index (BMI) is: kg/m^2.
Determination of MAC, MAMC, and TSF
Time frame: 5 months
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
1 secondary outcome
Hematological analysis
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 41971609Mughal H, Tufail T, Ain HBU, Rasheed A, Alum EU. Immunomodulatory Effects of Zinc and Selenium-Enriched Lentinula edodes Extract: Biochemical Characterization and Bioactivity Relevant to Tuberculosis. Food Sci Nutr. 2026 Apr 8;14(4):e71736. doi: 10.1002/fsn3.71736. eCollection 2026 Apr.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myrin P Fort, Zn + Se supplemented cookies and Zn + Se + Myrin P Fort in people with Immunomodulatory Drugs and Tuberculosis, run by University of Lahore at 1 site in Pakistan.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180329, which also lists 1 linked publication.
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 18 Sep 2025.