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PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers

NCT07316400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-05

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

PsP

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 & Collaborators

  • University of Brawijaya

    lead OTHER

Principal Investigators

  • Titin A Wihastuti, Professor · Brawijaya University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2024-10-26
Completion
2024-11-30

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316400 on ClinicalTrials.gov