Healthy Japanese subjects
Conditions
Interventions
Duration: 24 weeks Test food: Purified fish oil capsule containing docosahexaenoic acid Administration: Take four capsules after each meal. In total 12 capsules a day, taken three times daily. If yo
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged between 45 and 75 4. Healthy subjects 5. Subjects whose values of eGFRcreat are within the range of 45 =< eGFR < 90, and relatively low 6. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The calculated values of the creatinine-based estimated glomerular filtration rate (eGFRcreat) at 24 weeks after consumption (24w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The calculated values of the cystatin C-based estimated glomerular filtration rate (eGFRcys) at 24w 2. The amount of changes in eGFRcreat and eGFRcys between screening (before consumption; Scr)/pre-consumption examination (0w) and 24w 3. The calculated values of eGFRcreat, eGFRcys, and creatinine clearance (Ccr) at 12 weeks after consumption (12w), and the amount of changes from Scr and 0w 4. The measured values of body weight, systolic blood pressure, glucose (GLU), hemoglobin A1c {HbA1c: the National Glycohemoglobin Standardization Program (NGSP)}, high-density lipoprotein (HDL)-cholesterol (HDL-Cho), low-density lipoprotein (LDL)- cholesterol (LDL-Cho), and triglyceride (TG) at 12w and 24w, and the amount of changes from Scr and 0w 5. The measured values of 8-hydroxy-2'-deoxyguanosine (8-OHdG), kidney injury molecule-1 (KIM-1), liver-type fatty acid binding protein (L-FABP), N-acetyl-beta-D-glucosaminidase (NAG), comprehensive metabolite analysis (urine), albumin/creatinine, activated partial thromboplastin time (APTT), prothrombin time (PT), PT activity, PT-international normalized ratio (PT- INR), fatty acid fraction, comprehensive metabolite analysis (peripheral blood), the ratio of aldosterone/renin activity, urine sodium, urine potassium and urine chloride at 12w and 24w, and the amount of changes from and 0w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed