Protocol for a Randomized, Single-Blind, Controlled Clinical Trial Evaluating the Effect of Peptide Polysaccharide Supplementation on Serum Malondialdehyde, Interleukin-6, and Cotinine Levels

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.