Respiratory infections, fatigue, immune system, and digestive health of adults with moderate stress Other
Conditions
Interventions
Current interventions as of 30/01/2024:
This is a randomized, double-blind, placebo-controlled study designed to determine the efficacy of Yeast Beta Glucan 1,3/1,6 on respiratory infection, fatigue,
Sponsors
Mead Johnson Nutrition Malaysia
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 16/01/2024: 1. 18-59 years old 2. In a stressful environment 3. Scoring 14-26 (moderate stress) on the Perceived Stress Scale (PSS-10) 4. Symptoms of common colds in the past 6 months 5. Willing to comply with protocol requirements Previous inclusion criteria: 1. 18-60 years old 2. In a stressful environment 3. Scoring 14-26 (moderate stress) on the Perceived Stress Scale (PSS-10) 4. Symptoms of common colds in the past 6 months 5. Willing to comply with protocol requirements
Exclusion criteria
Exclusion criteria: 1. Participant on immunosuppressant (i.e., steroids) 2. Use of immune-modifying medications or dietary supplements affecting the immune system (at least 2 weeks of washing period for inclusion) 3. Any autoimmune or health concerns 4. Uncontrolled comorbidities including diabetes, hypertension, cardiovascular disease, chronic kidney disease, chronic liver disease, active malignancy, endocrine disorder and cancer 5. Uncontrolled chronic respiratory illness including allergic rhinitis or asthma, presence of nasal ulcers/polyps 6. Body temperature >38?C at study commencement 7. Pregnant/lactating female 8. On specific dietary requirements (diabetic diet/low salt diet/etc) 9. On prebiotics or probiotics supplementation (at least 2 weeks of washing period for inclusion) 10. On antibiotics washing period within 2 weeks for inclusion 11. Disabilities individuals- long-term physical, mental, intellectual and sensory impairment 12. Individuals without symptoms of common colds for the past 6 months 13. Allergy to yeast, oat, wheat, barley 14. Influenza vaccination for the past 1 year 15. Pneumococcal vaccine for the past 5 years 16. Participate in another research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/01/2024: 1. Upper respiratory tract infection (URTI) episodes: occurrence, severity and duration measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 at baseline, weeks 6 and 12. 2. Fatigue measured using the Profile of Mood State (POMS) at baseline and week 6 and 12. 3. Blood immune markers: cytokines interleukin: [IL] IL-6, IL 8, IL-10, TNF-interferon [IFN]-?, inflammation - CRP measured using blood samples at baseline and week 12. 4. Biomarkers and oxidative stress: oxidative stress (MDA, LPO), inflammatory biomarkers (iNOS, Cox2) measured at baseline and week 12. 5. Quality of life measured using Short Form-36 (SF-36) at baseline and weeks 4, 6 and 12. ______ Previous primary outcome measure: 1. Basic health profile (BMI, waist circumference, body fat percentage, complete blood count, fasting blood sugar, lipid profile, liver function test, renal function test) at baseline and week 12 2. Upper respiratory tract infection (URTI) episodes: occurrence, severity and duration measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 at baseline and weeks 4, 6 and 12 3. Blood immune markers: cytokines interleukin: [IL] IL-6, IL 8, IL-10, TNF-interferon [IFN]-?, inflammation - CRP measured using blood samples at baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/01/2024: 1.The gut bacterial diversity (a diversity, ß diversity, comparative analysis) and predicted functional analysis will be assessed at baseline and week 12 _____ Previous secondary outcome measures: 1. Fatigue measured using the Profile of Mood State (POMS) at baseline and weeks 4, 6 and 12 2. Biomarkers and oxidative stress: oxidative stress (MDA, LPO), inflammatory biomarkers (iNOS, Cox2) measured at baseline and week 12 3. Quality of life measured using Short Form-36 (SF-36) at baseline and weeks 4, 6 and 12 4. Microbiome abundance and functional analysis (a diversity, ß diversity, comparative analysis) at baseline and week 12 | — |
Countries
Malaysia
Outcome results
None listed