Oxidative Stress, Inflammation, Cigarette Smoking
Conditions
Keywords
Peptide Polysaccharide (PsP), Ganoderma lucidum, β-Glucan, Oxidative Stress, Inflammation, Smokers
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
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.
Interventions
DIETARY_SUPPLEMENTPsP
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.
Sponsors
University of Brawijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female adults aged 18 to 60 years. 2. Has smoked regularly for at least the past 12 months. 3. Able and willing to provide written informed consent. 4. Agrees to maintain usual smoking habits during the study period. 5. Able to comply with study procedures and visits.
Exclusion criteria
1. Current use of antioxidant supplements, vitamins, herbal supplements, or mushroom- derived products within the last 4 weeks. 2. Diagnosis of chronic inflammatory disease, autoimmune disease, diabetes mellitus, cardiovascular disease, chronic kidney disease, chronic liver disease, or cancer. 3. Acute illness, infection, or fever within the last 14 days. 4. Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids) within the last 4 weeks. 5. Participation in another clinical study within the past 30 days. 6. Pregnant or breastfeeding. 7. Known allergy to Ganoderma lucidum or mushroom-derived compounds. 8. Alcohol dependence or substance abuse other than tobacco.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Malondialdehyde (MDA) Levels | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Cotinine Levels | Baseline to 8 weeks | Serum cotinine concentration (ng/mL) will be measured as an objective biomarker of tobacco exposure to assess changes during the study period |
| Change in Serum Interleukin-6 (IL-6) Levels | Baseline to 8 weeks | Serum IL-6 concentration (pg/mL) will be measured to evaluate the inflammatory response following PsP supplementation compared with control |
| Change in Serum Cortisol Levels | Baseline to 8 weeks | Serum Cortisol concentration will be measured as an objective biomarker of tobacco exposure to assess changes during the study period |
| Change in Serum Nicotinic acetylcholine receptors (nAChRs) Levels | Baseline to 8 weeks | Serum nAChRs concentration (ng/mL) will be measured as an objective biomarker of tobacco exposure to assess changes during the study period |
| Change in Serum Nitric Oxide (NO) Levels | Baseline to 8 weeks | Serum NO concentration (µmol/L) will be measured to evaluate inflammatory response following PsP supplementation compared with control |
Countries
Indonesia
Outcome results
None listed