Safety evaluation of excessive consumption of the test food
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000040823
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Not provided
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. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS), or any other chronic diseases 4. Subjects regularly taking medications (including herbal medicines) and supplements 5. Subjects allergic to medications and/or soybeans 6. Subjects who are pregnant, lactating, or intending to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 8. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence of side effects 2. Incidence of adverse events
- Secondary Outcome Measures
Name Time Method 1. Physical examination 2. Urinalysis 3. Blood test