A verification study of the protection and improvement effects of the test food on kidney functio
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049881
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 84
Not provided
Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. are currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly seafood, soy or peanut) 7. are pregnant, lactating, or planning to become pregnant during this trial 8. suffer from COVID-19 9. 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. usually take medicines (diuretics, antihypertensive agents, sodium glucose cotransporter 2 (SGLT2) inhibitors, warfarin, uricosuric agents, or others), dietary supplements (claiming lowering effects of triglyceride, blood pressure, or blood glucose, or related to urination), or others which may influence the results of this study 11. have a past or current medical history of the following diseases: severe liver disorder, kidney disorder, heart disease, hepatitis, extreme anemia, alcohol dependency, hemorrhagic disease (hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract bleeding, hemoptysis, vitreous bleeding, or others) 12. require assistance, or have difficulty to walk independently 13. have seafood and fish roe at least 4 days per week 14. 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. The calculated values of the creatinine-based estimated glomerular filtration rate (eGFRcreat) at 24 weeks after consumption (24w)
- Secondary Outcome Measures
Name Time Method