Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing plant extract Administration: Take two tablet per day *Daily dose should be taken within the day. If you forget to take the test food, take it as s
Sponsors
Oryza Oil & Fat Chemical Co. Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in study by the physician 6. Subjects whose liver marker are normal (20<=ALT<=30), slightly high (31<=ALT<=50) or high (51<= ALT)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 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 participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of the ALT (GPT) at 12 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of the ALT (GPT) at four and 8 weeks after consumption 2. The measured value of AST (GOT), gamma-GT (gamma-GTP), LDL cholesterol, total cholesterol, triglyceride at four, 8 and 12 weeks after consumption 3. The questionnaire on fatigue at four, 8 and 12 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNorihito Shimizu
Oryza Oil & Fat Chemical Co. Ltd Planning & Solution Development Department
Outcome results
None listed