Healthy Japanese subjects
Conditions
Interventions
Duration: 1 week 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 forget
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 use dentures. 7. Subjects who have receiving treatment of periodontosis or with antimicrobial agents within the last three months. 8. Subjects who have receiving dental maintenance care, such as removing dental plaques and dental tartars within the last three months 9. Subjects who are under treatment or diagnosed with any of dental diseases. 10. Subjects who are allergic to medicines and/or the test food related products. 11. Subjects who are pregnant, breast-feeding, or planning to become pregnant. 12. Subjects who have been enrolled in other clinical trials within the last two months before the agreement to participate in this trial or plan to participate another trial during this trial. 13. 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 (Aa), P.gingivalis (Pg), P.intermedia (Pi), T.forsythensis (Tf), T.denticola (Td), F.nucleatum (Fn) * Measure the values at screening (before consumption) and 1 week after consumption and calculate the amount of change. | — |
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 * Measure the values at screening (before consumption) and 1 week after consumption and calculate the amount of change. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed