Healthy male/female adults
Conditions
Interventions
Ingestion of the test food (0.5 mL), twice a day
Ingestion of the placebo food (0.5 mL), twice a day
Sponsors
CPCC Company Limited
Chiyoda Oralhealth Care Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 30 to 69, at informed consent. (2) Subjects having a subjective symptom of dry mouth and halitosis. (3) Subjects who feel daily stress. (4) Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (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., antihistamine/ antidepressant/ antihypertensive/ antiinflammatory/painkiller), and have any difficulty in refraining from taking them during this study. (3) Subjects who use some kind of oral care product (e.g., mouthwash), and have any difficulty in refraining from using them during this study. (4) 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 (including scaling tartar and plaque). (5) Subjects who have been diagnosed as dry mouth or Sjogren's syndrome. (6) Subjects with salivary secretion of no more than 2 g, according to the results of the Saxon tests at the moment of preliminary examination. (7) Subjects fully realized that their gums are liable to bleed. (8) Subjects with excessive alcohol intakes. (9) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (10) Pregnant, lactating, possibly pregnant women during this study. (11) Subjects having drug/food allergy. (12) 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 participate in those after giving informed consent to take part in this study. (13) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary secretion volume (resting and stimulus) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Simplified questionnaire survey about mental stress (simple ver.: 23 questions) 2. Oral questionnaire 3. Halitosis 4. Cortisol in saliva 5. The Profile of Mood States Second Edition (Japanese short ver.) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed