Summary of activities and parameters involved according to study period data collection
Activities and parameters screening | Screening | Week 0 (baseline) | Week 6 | Week 12 | |
Enrolment | Eligibility 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 | ✓ | ✓ | |||
Study | Yeast 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 assessment | Safety 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 | ✓ | ✓ | ✓ |