PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers (NCT07316400) | Clinical Trial Compass
CompletedNot Applicable
PsP Ganoderma Lucidum Supplementation and Biomarker Changes in Smokers
Indonesia200 participantsStarted 2024-09-01
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.