Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing rice bran extract Administration: Take three capsules per day with water without chewing. *If you forget to take the test food, take it as soon as
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose ALT levels are between 31 U/L and 50 U/L at screening (before consumption; Scr) 6. Individuals whose AST levels are 50 U/L or less at Scr 7. Individuals whose gamma-GTP levels are 100 U/L or less at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test product related products 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who may change their usual amount and intensity of exercise between the agreement to participate and completion of this study 10. Individuals who plan to have surgery during this study and within two weeks after this study 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of alanine aminotransferase (ALT) levels at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of aspartate aminotransferase (AST) levels at 12w 2. The measured value of gamma-glutamyl transpeptidase (gamma-GTP) levels at 12w 3. The measured value of subjective fatigue measured by Visual analog scale (VAS) at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed