Table 3

Summary of activities and parameters involved according to study period data collection

Activities and parameters screeningScreeningWeek 0 (baseline)Week 6Week 12
EnrolmentEligibility screening
Moderate stress Perceived Stress Scale 10, Patient Health Questionnaire 9, Influenza and cold symptoms Jackson Cold Scale
Informed consent
Sociodemographic information
Medical history
Concomitant medication history
Allocation and randomization
Study product dispensing
StudyYeast beta-glucan (120 mg) sachets
Yeast beta-glucan (204 mg) sachets
Placebo sachets
Daily dose diary checking
Compliance checking and unused product return
Compliance and assessmentSafety and tolerability assessment vital signs adverse events
Primary outcomes
Respiratory Infection (Wisconsin Upper Respiratory Scale 21), Fatigue (Multidimensional Fatigue Inventory), Mood (Profile of Mood State), Quality of life (The Short Form 36)
Immune markers cytokines—interleukin: (IL) IL-6, IL 8, IL-10, TNF-α, interferon (IFN)-γ, inflammation -hsCRPOxidative stress (malondialdehyde, lipid peroxidation) and inflammatory biomarkers (iNOS, Cox2)
Secondary outcomes
Gut microbiota analysis
Other assessments
Anthropometric measurement
Blood plasma/serum analysis complete blood count, renal function test, liver function test, fasting blood sugar, lipid profile
3-day food record