Healthy Japanese subjects
Conditions
Interventions
Period I: Active hard capsule Period II: Placebo Administration: <
Take 1 capsule once a day after breakfast. *The intervention sequence is Period I to Period II, and each food is single ingestion.
Period I: Placebo Period II: Active hard capsule Administratio
Take 1 capsule once a day after breakfast. *The intervention sequence is Period I to Period II, and each food is single ingestion.
Sponsors
Oryza Oil & Fat Chemical Co. Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In-house employees 2. Healthy subjects who lack the moisture of the mouth 3. Subjects with low saliva volume at screening
Exclusion criteria
Exclusion criteria: 1. Subjects with low saliva production at screening test (< 2 g by Saxon test) 2. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction. 3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 4. 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. 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 6. Subjects who are currently taking medications (including herbal medicines) and supplements. 7. Subjects who are allergic to medicines and/or the test food related products. 8. Subjects who are pregnant, lactation, or planning to become pregnant. 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period. 10. Subjects who have history of respiratory disease or current illness. 11. Subjects with autoimmune disease. 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in saliva secretion after two weeks of start intake of the test food from screening test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of change in saliva secretion after one week of start intake of the test food from screening test. 2. Measured amount of saliva secretion after one week of start intake of the test food. 3. Measured amount of saliva secretion after two weeks of start intake of the test food. | — |
Countries
Japan
Contacts
Public ContactNozomi Yamauchi
Oryza Oil & Fat Chemical Co. Ltd Manufacturing Technology Department
Outcome results
None listed