Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test food
Duration: Four weeks Placebo
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged between 40 and 64 4. Healthy individuals 5. Individuals who are aware of catching colds easily and who caught colds in the last year 6. Individuals who feel fatigue on a daily basis
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are currently undergoing treatment for any of the following chronic diseases such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products 7. take the test food or similar foods 8. are pregnant, lactating, or planning to become pregnant during this study 9. have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during this study 10. have received vaccination for influenza or COVID-19 within the last three months before agreeing to participate 11. have pollen allergy such as Japanese red-cedar or cypress, or perennial allergic rhinitis 12. take foods which may affect the immune function such as mushroom, lactic acid bacteria, or Korean ginseng 13. have chronic fatigue syndrome, diagnosed a doctor based on persistent fatigue lasting for six months. 14. are smokers or have quit smoking within the last year before the agreement to participate 15. plan to have surgery within two weeks after the last consumption 16. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 17. have irregular sleeping time or habit due to work such as a late-night shift 18. have irregular lifestyles (such as diet, exercise, and sleep) 19. are undergoing medical treatment for menopausal syndrome 20. work in physical labor such as transportation of heavy objects 21. are judged as ineligible to participate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The cumulative number of onset days with common cold-like symptoms during the intervention period per participant | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immune-related biomarkers (dynamics of immune cells, antibodies, and cytokines) 2. The maximum duration of the onset days with common cold-like symptoms during the intervention period per participant 3. The cumulative number and the maximum duration of the onset days with each symptom (whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, nasal congestion, throat pain, cough, joint pain, and muscle pain) during the intervention period per participants | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed