Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test materials: HGH crystal Dose: 1 pack, three times per day Administration: Maintain the test food in the mouth for 40 seconds and swallow it before each meal. * If you forge
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects who have no tooth decay. 2. 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 or myocardial infarction. 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases. 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements. 6. Subjects who are identified at least severe tooth decay by dentist. 7. Subjects who use implants, tooth caps, dentures, and bridges. 8. Subjects who have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months. 9. Subjects who have received dental maintenance care, such as removing dental plaques and dental tartars within the last three months. 10. Subjects who are under treatment or diagnosed with any of dental diseases. 11. Subjects who regularly use floss, interdental cleaner, and mouthwash. 12. Subjects who are allergic to medicines and/or the test food related products. 13. Subjects who are pregnant, breast-feeding, or planning to become pregnant. 14. Subjects who 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. 15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. actinomycetemcomitans, P. gingivalis, P. intermedia, T. forsythensis, T. denticola, F. nucleatum * Measure the values at screening (before consumption) and 4 weeks after consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analogue Scale (VAS) of subjective symptoms Halitosis, swelling of gums, surface roughness of tooth, oral discomfort, dry mouth, and, stickiness in the mouth 2. The concentration of serum IGF-1 3. The concentration of salivary IGF-1 * Measure the values at screening (before consumption) and 4 weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed