Confirmation study of improvement effects by test-food intakes in oral environment
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000048862
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional (e.g., reduced coenzyme Q10-containing)/supplementary/ health foods, which might affect the test results. (2) Subjects who have taken affecting medicines (e.g., antifungal/antibiotic/ antihistamine/antidepressant/ antihypertensive), and have any difficulty in refraining from taking them during this study. (3) Subjects who have been to the hospital for dental treatment within three months prior to the consent, or those who are now under the treatment (except taking a periodic dental checkup). (4) Subjects equipped with full dentures. (5) Subjects who might cast off their capped teeth during this study, or are planning to be under dental treatment. (6) Subjects who take a daily care of their tongue. (7) Subjects who have been diagnosed as dry mouth or Sjogren's syndrome. (8) Subjects fully realized that their gums are liable to bleed. (9) Subjects with excessive alcohol intakes. (10) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (11) Pregnant, lactating, possibly pregnant women during this study. (12) Subjects having drug/food allergy. (13) Subjects who are now under other clinical studies with some kind of medicine and/or health food, or partook in those within four weeks before this study, or are going to take part in those after giving informed consent to participate in this study. (14) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oral bacteria test
- Secondary Outcome Measures
Name Time Method 1. Oral candida test 2. Tongue Coating Index score 3. Oral questionnaire 4. The Profile of Mood States Second Edition (Japanese short ver.)