Healthy Japanese subjects
Conditions
Interventions
<
Duration: Three days Test food: Chewable tablet containing proanthocyanidins derived from Acacia Bark Administration: Take one tablet with not chewing but licking three times a day after every meal
Duration: Three days Test food: Placebo chewable tablet Administration: Take one tablet with not chewing but licking three times a day after every meal *Daily dose should be taken within the day.
Duration: Three days Test food: Placebo chewable tablet Administration: Take one tablet with not chewing but licking three times a day after every meal <
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. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose plaque index is high at screening (before consumption) 6. Subjects who are judged as eligible to participate in the study by the physician
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 diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who use artificial tooth, post crowns, dentures, implants or bridges 8. Subjects who are undergoing medical treatment for periodontosis or dental caries 9. Subjects who use dental floss, interdental brush, or mouthwash when brushing their teeth 10. Subjects who have received dental maintenance care (such as removing dental plaques or dental tartars) at the dental clinic within the last three months 11. Subjects who have diseases associated with salivary gland such as dry mouse and salivary stone disease 12. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 13. Subjects who suffer from COVID-19 14. 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 15. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plaque index | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral flora | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed