A verification study to evaluate the safety of excessive consumption of the test food
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000053681
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 11
Not provided
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 have thyroid disease 5. Individuals who are aspirin hypersensitivity 6. Individuals who have hypotension (a systolic blood pressure less than 100 mmHg) 7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. Individuals who are taking or using medications (including herbal medicines) and supplements 9. Individuals who are allergic to medicines and/or the test food related products 10. Individuals who are pregnant, lactating, or planning to become pregnant during this study 11. 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 12. Individuals who are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Individuals who experienced adverse events
- Secondary Outcome Measures
Name Time Method 1. Individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption)