Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: <
Test food A <
Test food B *The intervention sequence is Test 1 to Test 2. *Washout period is for four weeks and more.
Duration: Four weeks Test product: <
Test food B <
Test food A *The intervention sequence is Test 1 to Test 2. *Washout period is for four weeks and more.
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 20 or more and less than 59 4. Healthy individuals 5. Individuals whose stimulated salivary flow rate (by gum test) is >10 mL/10 min at screening 6. Individuals who feel dryness in the mouth daily
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines or foods related to the test products, particularly those who are allergic to green tea 7. Individuals who are currently on medication or undergoing outpatient treatment 8. Individuals who regularly use foods or medications that alleviate dryness in the mouth or affect thirst in the mouth 9. Individuals who are participating or plan to participate in other clinical studies 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. Individuals who have a medical history or current history of Sjogren's syndrome, or who are suspected of it 12. Individuals who have a medical history or current history of diseases associated with salivary gland such as xerostomia 13. Individuals who are smokers 14. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The rate of change of stimulated salivary flow rate at four weeks after consumption (4w) from before consumption (0w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value and logarithmic value of stimulated salivary flow rate at 4w, and the amount of change of it from 0w 2. Individuals whose responses to the questionnaire on quality of life (QOL) about oral function are improved at 4w from 0w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed