Healthy male/female adults
Conditions
Interventions
Consumption of the test food (4 drops/day)
Consumption of the placebo food (4 drops/day)
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 40 to 64, at informed consent. (2) Subjects having a subjective symptom of dry mouth. (3) Subjects who can give informed consent to participate 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), 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 who have been diagnosed as dry mouth or Sjogren's syndrome. (5) Subjects with salivary secretion of less than 2 g at the moment of preliminary examination. (6) Subjects fully realized that their gums are liable to swell up and bleed. (7) Subjects with excessive alcohol intakes. (8) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (9) Subjects who have been diagnosed as diabetes, or are now under medical treatment for the disease. (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 participate in those within four weeks before this study, or are going to took part in those after giving informed consent to take part in this study. (13) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary secretion volume by Saxon test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood-flow measurement (fingertip and the mouth) 2. Subjective questionnaire | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed