A verification study of improving on the oral cavity environment of the test food: an open-label trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000034948
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Morinaga H, Tanaka M. HGH Crystal MD(R) improves the oral environment-an open-label, observational before-after study-. Jpn Pharmacol Ther. 2019; 47(8): 1297-1313.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 11
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.