Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Test food: Tablet containing champignon extract Administration: Take three tablets per day at any time during the day * Daily dose should be taken within the day. If you for
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic Medical Corporation Yuseikai, Horiuchi Dental Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are anxious about halitosis 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose total score of questionnaire for halitosis is between 14 and 21 at Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects who regularly use antimicrobial drugs 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products 8. Subjects who regularly use mouthwashes 9. Subjects who use artificial tooth, post crowns, dentures, implants, and bridges 10. Subjects who have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months 11. Subjects who have a medical history, current illness, or are suspected to be a Sjogren's syndrome 12. Subjects who suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease 13. Subjects who are being treated periodontosis or dental caries 14. Subjects whose salivary secretion volume at rest is less than 1.0 g/10 min 15. Subjects who are smokers 16. Subjects who are pregnant, breast-feeding, and planning to become pregnant 17. Subjects who suffer from COVID-19 18. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 19. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The total score of questionnaire for halitosis at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change of the total score of questionnaire for halitosis between screening (before consumption; Scr) and 8w 2. The measured values and amount of change from Scr in each of the following items at 8w: the total scores of each domain of questionnaire for halitosis, the each question items of visual analog scale, the each score of Profile of Mood States 2nd Edition (POMS2) Japanese version {Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F)}, volatile sulfur compounds in the oral cavity, tongue coating score, oral moisture values, and the volume of saliva at rest 3. The measured values of each question items of POMS2 at 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed