Oxidative StressPSPGLNCT07316400
PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers
A study testing PsP in people with Oxidative Stress and Inflammation, run by University of Brawijaya at 1 site in Indonesia.
Trial summary
The goal of this randomized controlled clinical trial is to evaluate whether polysaccharide peptide (PsP) supplementation from Ganoderma lucidum can modulate biomarkers of oxidative stress, inflammation, nicotine exposure, and stress response in adults exposed to cigarette smoke. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation, Cigarette Smoking
- What is being tested?
- PsP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2024to 30 Nov 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults aged 18 to 60 years.
- Has smoked regularly for at least the past 12 months.
- Able and willing to provide written informed consent.
- Agrees to maintain usual smoking habits during the study period.
- Able to comply with study procedures and visits.
Who cannot join
- Current use of antioxidant supplements, vitamins, herbal supplements, or mushroom- derived products within the last 4 weeks.
- Diagnosis of chronic inflammatory disease, autoimmune disease, diabetes mellitus, cardiovascular disease, chronic kidney disease, chronic liver disease, or cancer.
- Acute illness, infection, or fever within the last 14 days.
- Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids) within the last 4 weeks.
- Participation in another clinical study within the past 30 days.
- Pregnant or breastfeeding.
- Known allergy to Ganoderma lucidum or mushroom-derived compounds.
- Alcohol dependence or substance abuse other than tobacco.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for a Randomized, Single-Blind, Controlled Clinical Trial Evaluating the Effect of Peptide Polysaccharide Supplementation on Serum Malondialdehyde, Interleukin-6, and Cotinine Levels
The goal of this randomized controlled clinical trial is to evaluate whether polysaccharide peptide (PsP) supplementation from Ganoderma lucidum can modulate biomarkers of oxidative stress, inflammation, nicotine exposure, and stress response in adults exposed to cigarette smoke. The study is conducted in adults aged 20-50 years with active or passive exposure to cigarette smoke.
The main questions it aims to answer are:
Read more
- Does PsP supplementation change serum malondialdehyde (MDA) and superoxide dismutase (SOD) levels over 8 weeks?
- Does PsP supplementation affect serum interleukin-6 (IL-6), nitric oxide (NO), cotinine, nicotinic acetylcholine receptor (nAChR), and cortisol levels?
Researchers will compare participants receiving PsP supplementation with those receiving a placebo to evaluate differences in changes in the specified biomarkers.
Participants will:
- Be randomly assigned to receive PsP capsules (500 mg/day) or placebo for 8 weeks
- Provide fasting blood samples at baseline and at the end of the intervention
- Maintain usual lifestyle habits while avoiding antioxidant supplements during the study period
Read the detailed description
Cigarette smoke exposure is associated with increased oxidative stress and inflammatory responses, largely mediated by excessive production of reactive oxygen species. These processes contribute to elevated levels of lipid peroxidation products and proinflammatory cytokines, as well as measurable biomarkers of nicotine exposure and stress-related physiological responses. Individuals with active or passive exposure to cigarette smoke may therefore experience sustained biochemical alterations linked to oxidative and inflammatory burden.
Polysaccharide peptide (PsP) derived from Ganoderma lucidum is composed primarily of β-(1,3)/(1,6)-D-glucans and peptide fractions that have demonstrated antioxidant and immunomodulatory activity in experimental and preclinical studies. Despite growing interest in PsP as a functional nutritional supplement, clinical evidence evaluating its effects on oxidative stress and inflammation in smoke-exposed human populations remains limited.
This randomized, single-blind, placebo-controlled clinical trial is designed to assess the effects of PsP supplementation on selected serum biomarkers related to oxidative stress, inflammation, nicotine exposure, and stress response. Eligible participants are adults aged 20-50 years with documented active or passive exposure to cigarette smoke. Participants are randomly assigned in a 1:1 ratio to receive either PsP supplementation or a visually identical placebo for a period of 8 weeks.
Participants assigned to the intervention group receive PsP capsules at a total daily dose of 500 mg, administered as one 250 mg capsule twice daily. Each capsule contains standardized amounts of total polysaccharides, including β-glucans, and peptide fractions. The control group receives placebo capsules containing inert excipients with no known biological activity. All study products meet applicable pharmacopeial standards for quality and safety. Adherence to the intervention is monitored through capsule counts and participant-maintained compliance logs.
Fasting blood samples are collected at baseline and at the end of the intervention period. Serum is separated and stored under controlled conditions until analysis. Laboratory assessments are planned using validated analytical methods to quantify biomarkers of oxidative stress, antioxidant activity, inflammation, nicotine exposure, receptor-related parameters, and stress-related hormones.
The primary outcome measures include changes in serum malondialdehyde (MDA) and superoxide dismutase (SOD) concentrations from baseline to week 8. Secondary outcome measures include changes in serum interleukin-6 (IL-6), nitric oxide (NO), cotinine, nicotinic acetylcholine receptor (nAChR) levels, and cortisol concentrations over the same period.
The planned statistical analysis includes descriptive summaries of baseline characteristics and inferential analyses to compare changes in outcome measures between study groups and within groups over time. Appropriate statistical methods are prespecified to account for baseline variability. All analyses are conducted using two-tailed tests with a prespecified level of statistical significance.
- Conditions
- Oxidative Stress, Inflammation, Cigarette Smoking
- Being tested
- PsP
- Keywords
- Peptide Polysaccharide (PsP), Ganoderma lucidum, β-Glucan, Oxidative Stress, Inflammation, Smokers
- Medical subject headings
- Inflammation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsPDietary supplement
PsP is a freeze dried Ganoderma lucidum Polysaccharide Peptide extract from mycelium cell wall. Each capsule contains 250 mg of Polysaccharide Peptide, which it equal to 180 mg β-1,3/1,6-D-Glucan.
| Study group | Role | What they receive |
|---|---|---|
| Smoker Control Group (No Supplementation) | No intervention | Participants in this arm are smokers who do not receive any investigational product. They continue with their usual daily habits without additional supplements or treatments. This group serves as the control for evaluating the effects of PsP Ganoderma lucidum. |
| Smokers Receiving PsP Ganoderma lucidum Supplementation | Experimental | Participants in this arm are smokers who receive PsP Ganoderma lucidum as the investigational intervention. They follow the assigned PsP supplementation regimen for the full study duration to assess its effects compared with the control group. Receives: Dietary Supplement: PsP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Malondialdehyde (MDA) Levels
Serum MDA concentration (nmol/mL) will be measured to assess oxidative stress status in participants receiving PsP compared with the control group
Measured: Baseline to 8 weeks
Change in Serum Superoxide Dismutase (SOD) Levels
Serum SOD concentration (U/mL) will be measured to assess oxidative stress status in participants receiving PsP compared with the control group
Measured: Baseline to 8 weeks
Secondary outcomes (5)
Change in Serum Interleukin-6 (IL-6) Levels
Serum IL-6 concentration (pg/mL) will be measured to evaluate the inflammatory response following PsP supplementation compared with control
Measured: Baseline to 8 weeks
Change in Serum Nitric Oxide (NO) Levels
Serum NO concentration (µmol/L) will be measured to evaluate inflammatory response following PsP supplementation compared with control
Measured: Baseline to 8 weeks
Change in Serum Cotinine Levels
Serum cotinine concentration (ng/mL) will be measured as an objective biomarker of tobacco exposure to assess changes during the study period
Measured: Baseline to 8 weeks
Change in Serum Nicotinic acetylcholine receptors (nAChRs) Levels
Serum nAChRs concentration (ng/mL) will be measured as an objective biomarker of tobacco exposure to assess changes during the study period
Measured: Baseline to 8 weeks
Change in Serum Cortisol Levels
Serum Cortisol concentration will be measured as an objective biomarker of tobacco exposure to assess changes during the study period
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Sep 2024
- Primary completion26 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel design in which adult smokers are randomly assigned to either a control group (smokers without supplementation) or an intervention group (smokers receiving peptide polysaccharide supplementation). Both groups are followed concurrently throughout the study period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Titin Andri Wihastuti, University of Brawijaya
- Investigators
- Titin A Wihastuti, Professor, Principal investigator, Brawijaya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316400
- Sponsor's protocol ID
- 12757/UN10.F17.10.4/TU/2024
- Other IDs
- 01884.4/UN10.A0501/B/KS/2025
- Acronym
- PSPGL
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study does not include a data-sharing plan in the ethics approval or informed consent. Data contain sensitive biomarker and smoking-related information that may pose a re-identification risk for participants. Therefore, IPD will not be made publicly available.
Publications
Kumboyono K, Chomsy IN, Hakim AK, Sujuti H, Hariyanti T, Srihardyastutie A, Wihastuti TA. Detection of Vascular Inflammation and Oxidative Stress by Cotinine in Smokers: Measured Through Interleukin-6 and Superoxide Dismutase. Int J Gen Med. 2022 Sep 16;15:7319-7328. doi: 10.2147/IJGM.S367125. eCollection 2022.
PubMed 36147199Kumboyono K, Nurwidyaningtyas W, Chomsy IN, Wihastuti TA. Early Detection of Negative Smoking Impacts: Vascular Adaptation Deviation Based on Quantification of Circulated Endothelial Activation Markers. Vasc Health Risk Manag. 2021 Mar 23;17:103-109. doi: 10.2147/VHRM.S296293. eCollection 2021.
PubMed 33790567Wihastuti TA, Heriansyah T. The inhibitory effects of polysaccharide peptides (PsP) of Ganoderma lucidum against atherosclerosis in rats with dyslipidemia. Heart Int. 2017 Apr 12;12(1):e1-e7. doi: 10.5301/heartint.5000234. eCollection 2017 Jan-Dec.
PubMed 29114382
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized, Single-Blind, Controlled Clinical Trial Evaluating the Effect of Peptide Polysaccharide Supplementation on Serum Malondialdehyde, Interleukin-6, and Cotinine Levels
- ClinicalTrials.gov ID
- NCT07316400
- Acronym / sponsor ID
- PSPGL / 12757/UN10.F17.10.4/TU/2024
- Conditions
- Oxidative Stress, Inflammation, Cigarette Smoking
- Keywords
- Peptide Polysaccharide (PsP), Ganoderma lucidum, β-Glucan, Oxidative Stress, Inflammation, Smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Jan 2026 (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 goal of this randomized controlled clinical trial is to evaluate whether polysaccharide peptide (PsP) supplementation from Ganoderma lucidum can modulate biomarkers of oxidative stress, inflammation, nicotine exposure, and stress response in adults exposed to cigarette smoke. The study is conducted in adults aged 20-50 years with active or passive exposure to cigarette smoke.
The main questions it aims to answer are:
- Does PsP supplementation change serum malondialdehyde (MDA) and superoxide dismutase (SOD) levels over 8 weeks?
- Does PsP supplementation affect serum interleukin-6 (IL-6), nitric oxide (NO), cotinine, nicotinic acetylcholine receptor (nAChR), and cortisol levels?
Researchers will compare participants receiving PsP supplementation with those receiving a placebo to evaluate differences in changes in the specified biomarkers.
Participants will:
- Be randomly assigned to receive PsP capsules (500 mg/day) or placebo for 8 weeks
- Provide fasting blood samples at baseline and at the end of the intervention
- Maintain usual lifestyle habits while avoiding antioxidant supplements during the study period
Detailed description
Cigarette smoke exposure is associated with increased oxidative stress and inflammatory responses, largely mediated by excessive production of reactive oxygen species. These processes contribute to elevated levels of lipid peroxidation products and proinflammatory cytokines, as well as measurable biomarkers of nicotine exposure and stress-related physiological responses. Individuals with active or passive exposure to cigarette smoke may therefore experience sustained biochemical alterations linked to oxidative and inflammatory burden.
Polysaccharide peptide (PsP) derived from Ganoderma lucidum is composed primarily of β-(1,3)/(1,6)-D-glucans and peptide fractions that have demonstrated antioxidant and immunomodulatory activity in experimental and preclinical studies. Despite growing interest in PsP as a functional nutritional supplement, clinical evidence evaluating its effects on oxidative stress and inflammation in smoke-exposed human populations remains limited.
This randomized, single-blind, placebo-controlled clinical trial is designed to assess the effects of PsP supplementation on selected serum biomarkers related to oxidative stress, inflammation, nicotine exposure, and stress response. Eligible participants are adults aged 20-50 years with documented active or passive exposure to cigarette smoke. Participants are randomly assigned in a 1:1 ratio to receive either PsP supplementation or a visually identical placebo for a period of 8 weeks.
Participants assigned to the intervention group receive PsP capsules at a total daily dose of 500 mg, administered as one 250 mg capsule twice daily. Each capsule contains standardized amounts of total polysaccharides, including β-glucans, and peptide fractions. The control group receives placebo capsules containing inert excipients with no known biological activity. All study products meet applicable pharmacopeial standards for quality and safety. Adherence to the intervention is monitored through capsule counts and participant-maintained compliance logs.
Fasting blood samples are collected at baseline and at the end of the intervention period. Serum is separated and stored under controlled conditions until analysis. Laboratory assessments are planned using validated analytical methods to quantify biomarkers of oxidative stress, antioxidant activity, inflammation, nicotine exposure, receptor-related parameters, and stress-related hormones.
The primary outcome measures include changes in serum malondialdehyde (MDA) and superoxide dismutase (SOD) concentrations from baseline to week 8. Secondary outcome measures include changes in serum interleukin-6 (IL-6), nitric oxide (NO), cotinine, nicotinic acetylcholine receptor (nAChR) levels, and cortisol concentrations over the same period.
The planned statistical analysis includes descriptive summaries of baseline characteristics and inferential analyses to compare changes in outcome measures between study groups and within groups over time. Appropriate statistical methods are prespecified to account for baseline variability. All analyses are conducted using two-tailed tests with a prespecified level of statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A two-arm parallel design in which adult smokers are randomly assigned to either a control group (smokers without supplementation) or an intervention group (smokers receiving peptide polysaccharide supplementation). Both groups are followed concurrently throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Smoker Control Group (No Supplementation) | No intervention | –Participants in this arm are smokers who do not receive any investigational product. They continue with their usual daily habits without additional supplements or treatments. This group serves as the control for evaluating the effects of PsP Ganoderma lucidum. |
| Smokers Receiving PsP Ganoderma lucidum Supplementation | Experimental | Dietary Supplement: PsPParticipants in this arm are smokers who receive PsP Ganoderma lucidum as the investigational intervention. They follow the assigned PsP supplementation regimen for the full study duration to assess its effects compared with the control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female adults aged 18 to 60 years.
- Has smoked regularly for at least the past 12 months.
- Able and willing to provide written informed consent.
- Agrees to maintain usual smoking habits during the study period.
- Able to comply with study procedures and visits.
Key exclusion criteria (8 listed)
- Current use of antioxidant supplements, vitamins, herbal supplements, or mushroom- derived products within the last 4 weeks.
- Diagnosis of chronic inflammatory disease, autoimmune disease, diabetes mellitus, cardiovascular disease, chronic kidney disease, chronic liver disease, or cancer.
- Acute illness, infection, or fever within the last 14 days.
- Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids) within the last 4 weeks.
- Participation in another clinical study within the past 30 days.
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 |
|---|---|---|
| PsPPsP is a freeze dried Ganoderma lucidum Polysaccharide Peptide extract from mycelium cell wall. Each capsule contains 250 mg of Polysaccharide Peptide, which it equal to 180 mg β-1,3/1,6-D-Glucan. | Dietary supplement | Smokers Receiving PsP Ganoderma lucidum Supplementation |
Primary outcome
Change in Serum Malondialdehyde (MDA) Levels
Time frame: Baseline to 8 weeks
Serum MDA concentration (nmol/mL) will be measured to assess oxidative stress status in participants receiving PsP compared with the control group
Change in Serum Superoxide Dismutase (SOD) Levels
Time frame: Baseline to 8 weeks
Serum SOD concentration (U/mL) will be measured to assess oxidative stress status in participants receiving PsP compared with the control group
5 secondary outcomes
Change in Serum Interleukin-6 (IL-6) Levels
Time frame: Baseline to 8 weeks
Change in Serum Nitric Oxide (NO) Levels
Time frame: Baseline to 8 weeks
Change in Serum Cotinine Levels
Time frame: Baseline to 8 weeks
Change in Serum Nicotinic acetylcholine receptors (nAChRs) Levels
Time frame: Baseline to 8 weeks
Change in Serum Cortisol Levels
Time frame: Baseline to 8 weeks
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 5 Jan 2026.
- Background: PubMed 36147199Kumboyono K, Chomsy IN, Hakim AK, Sujuti H, Hariyanti T, Srihardyastutie A, Wihastuti TA. Detection of Vascular Inflammation and Oxidative Stress by Cotinine in Smokers: Measured Through Interleukin-6 and Superoxide Dismutase. Int J Gen Med. 2022 Sep 16;15:7319-7328. doi: 10.2147/IJGM.S367125. eCollection 2022.
- Background: PubMed 33790567Kumboyono K, Nurwidyaningtyas W, Chomsy IN, Wihastuti TA. Early Detection of Negative Smoking Impacts: Vascular Adaptation Deviation Based on Quantification of Circulated Endothelial Activation Markers. Vasc Health Risk Manag. 2021 Mar 23;17:103-109. doi: 10.2147/VHRM.S296293. eCollection 2021.
- Background: PubMed 29114382Wihastuti TA, Heriansyah T. The inhibitory effects of polysaccharide peptides (PsP) of Ganoderma lucidum against atherosclerosis in rats with dyslipidemia. Heart Int. 2017 Apr 12;12(1):e1-e7. doi: 10.5301/heartint.5000234. eCollection 2017 Jan-Dec.
- Product information for PsP (Peptide Polysaccharide) Ganoderma lucidum supplement, including composition, manufacturing details, and general product background provided by the manufacturer.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study does not include a data-sharing plan in the ethics approval or informed consent. Data contain sensitive biomarker and smoking-related information that may pose a re-identification risk for participants. Therefore, IPD will not be made publicly available.
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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.
Titin A Wihastuti, Professor principal investigator
Brawijaya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PsP in people with Oxidative Stress and Inflammation, run by University of Brawijaya at 1 site in Indonesia.
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 5 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: finished, as of the sponsor's last update on 5 Jan 2026. 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 Indonesia. 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?
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?
Change in Serum Malondialdehyde (MDA) Levels (time frame: Baseline to 8 weeks). 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 NCT07316400, which also lists 3 linked publications.
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 5 Jan 2026.