PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers

NCT07316400 | Completed DMC

• 2 other identifiers: 12757/UN10.F17.10.4/TU/202401884.4/UN10.A0501/B/KS/2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Oxidative Stress; Inflammation; Cigarette Smoking

Keywords

Peptide Polysaccharide (PsP); Ganoderma lucidum; β-Glucan; Oxidative Stress; Inflammation; Smokers

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline to 8 weeks

Secondary Outcomes (5)

• Change in Serum Interleukin-6 (IL-6) Levels

  Baseline to 8 weeks

• Change in Serum Nitric Oxide (NO) Levels

  Baseline to 8 weeks

• Change in Serum Cotinine Levels

  Baseline to 8 weeks

• Change in Serum Nicotinic acetylcholine receptors (nAChRs) Levels

  Baseline to 8 weeks

• Change in Serum Cortisol Levels

  Baseline to 8 weeks

Study Arms (2)

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.

Dietary Supplement: PsP

Interventions

PsP DIETARY_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.

Smokers Receiving PsP Ganoderma lucidum Supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brawijaya: lead

Study Sites (1)

University of Brawijaya

Malang, East Java, 65145, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 36147199 BACKGROUND

• Kumboyono 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.

  PMID: 33790567 BACKGROUND

• Wihastuti 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.

  PMID: 29114382 BACKGROUND

Related Links

• Product information for PsP (Peptide Polysaccharide) Ganoderma lucidum supplement, including composition, manufacturing details, and general product background provided by the manufacturer.

MeSH Terms

Conditions

Inflammation; Cigarette Smoking

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Titin A Wihastuti, Professor

  Brawijaya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group allocation, with PsP and placebo capsules identical in appearance and packaging. Investigators conducting laboratory analyses were also blinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Professor)

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 5, 2026
• Study Start: September 1, 2024
• Primary Completion: October 26, 2024
• Study Completion: November 30, 2024
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)