Healthy volunteers
Conditions
Interventions
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese males and females aged 20 years or older but under 65 at the time of consent. (2) Individuals who consider themselves prone to catching colds. (3) Individuals who have had an acute upper respiratory tract infections within the past two years. (4) Individuals who have health examination results from the past year and showing no findings that requiring treatment. (5) Individuals who have received sufficient explanation about the study and signed the informed consent form prior to participation.
Exclusion criteria
Exclusion criteria: 1) Individuals with malignant tumors, heart failure, or myocardial infarction (current or past). 2) Individuals with current or past treatment for: [1] Arrhythmia, liver dysfunction, renal impairment, cerebrovascular disease, thyroid disorders, gastrointestinal diseases, rheumatoid arthritis, diabetes, dyslipidemia, hypertension, or other chronic illnesses [2] Bronchial asthma or chronic bronchitis 3) Individuals with drug or alcohol dependence (current or past). 4) Individuals with hay fever or allergic rhinitis. 5) Individuals with mental disorders, depressive symptoms, or under treatment for such conditions. 6) Individuals with food allergies or potential allergy to the test food. 7) Individuals regularly using prescription or quasi-drugs affecting study outcomes and unable to discontinue during the study. 8) Individuals regularly consuming health foods affecting study outcomes and unable to discontinue during the study. 9) Individuals consuming excessive alcohol. 10) Heavy smokers. 11) Individuals unable to abstain from alcohol and smoking from the day before each visit until the end of the examination. 12) Individuals unable to maintain usual lifestyle. 13) Individuals with extremely irregular habits (e.g., night shift workers). 14) Individuals scheduled for vaccination during the study. 15) Individuals planning overseas travel during the study. 16) Individuals who are pregnant, breastfeeding, or planning pregnancy during the study. 17) Individuals who participated in another clinical trial within 1 month prior to consent or plan to participate during the study. 18) Individuals deemed inappropriate by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune Function Assessment Test | — |
Secondary
| Measure | Time frame |
|---|---|
| Likert-Type Scale | — |
Countries
Japan
Contacts
Public ContactMasako Mizuuchi
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed