Clinical Trial

PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers

Study acronym: PSPGL
Completed
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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
Trial Details
NCT Number NCT07316400
Lead Sponsor University of Brawijaya
Conditions Oxidative Stress, Inflammation, Cigarette Smoking
Enrollment 200 participants
Start Date 2024-09-01
Primary Completion 2024-10-26 (estimated)
Study Completion 2024-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-05