Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test food: Test food Administration: Take 1 tablet, three times a day. * If you forget to take the tablet, take it as soon as you remember within the day.
Duration: 8 weeks Tes
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who feel thirsty in the mouth 3. Subjects who are judged as ineligible to participate in the study by the physician 4. Subjects whose saliva test (Saxon test) is 2 g or more in 2 minutes 5. Subjects whose oral moisture level [using Mucus (R)] is relatively low 6. Subjects whose VAS values of subjective mouth dryness is relatively high
Exclusion criteria
Exclusion criteria: Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are undergoing medical treatment or have a medical history of a salivary gland disorder (including sialadenitis, sialolithiasis, Sjogren's syndrome, and salivary gland tumors), or Subjects who removed a salivary gland 4. are undergoing medical treatment of autoimmune disease 5. are currently undergoing treatment for the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or any other chronic diseases 6. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. are currently taking medicines (include herbal medicines) and supplements 8. buy more than 2 packs of 9 chewing gum sheets or 14 to 20 chewing gum a month, or eat about 40 chewing gum a month 9. are smokers 10. use implants, tooth caps, dentures, and bridges 11. have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months 12. have receiving dental maintenance care, such as removing dental plaques and dental tartars within the last three months 13. are under treatment or diagnosed with any of dental diseases 14. regularly use floss, interdental cleaner, and mouthwash 15. are allergic to medicines and/or the test food related products 16. are pregnant, lactation, or planning to become pregnant 17. have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 18. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of changes of visual analogue scale (VAS) values of subjective mouth dryness between at screening (before test-food consumption; Scr) and 8 weeks after the start of test-food consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of changes of VAS values in the subjective symptom of mouth dryness between at Scr and 4 weeks after the start of test-food consumption (4w) 2. The amount of changes in the following items between at Scr and 4w, and 8w VAS values of subjective symptoms of longing for drinking, difficulty eating and oral consistency; the volume of saliva; salivary amylase concentration; oral moisture values; and volatile sulfur compounds in the oral cavity 3. The logarithmic transformation values or the amount of changes in the following items between at Scr and 4w, and 8w Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola 4. The ratio of subjects whose measured VAS values of subjective mouth dryness at 8w decreasing by 50% or more compared to Scr. 5. The ratio of subjects whose measured VAS values of subjective mouth dryness at 8w decreasing by 25% or more compared to Scr. 6. The ratio of subjects whose oral moisture level 8w decreasing compared to Scr. 7. The ratio of subjects whose oral moisture values at 8w is 28.0 or more. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed