Effects of consumption of the test food on liver functio
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000044005
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 74
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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, hepatitis B, hepatitis C, or any other chronic diseases 4. Subjects who have a habit of drinking an average of 60 g or more of pure alcohol per day on a weekly 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects allergic to medications and/or the test-food-related products. Particularly allergic to shrimp, crab, egg, wheat, soba (buckwheat), peanut, and milk 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 participate another trial during this trial 10. 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 The measured values of serum alanine aminotransferase (ALT) at 24 weeks after the start of test-food consumption (24w)
- Secondary Outcome Measures
Name Time Method