A clinical study to evaluate the effects of fish oil containing DHA on the preservation of renal functio
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000036384
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 35
Not provided
1) Subjects who take medicines having the effect on the present study (diuretics, antihypertensive agents, SGLT2 inhibitors, warfarin, uricosuric agents, etc.) 2) Subjects who take foods for specified health uses, foods with function claims labeled or supplements (reducing triglycerides, blood pressure, blood glucose and having the effects on dysuria) which can affect the data in a main study 3) Subjects with dysuria who cannot collect their urine 4) Subjects receiving a medical history of serious liver disorder, renal disorder or heart diseases 5) Subjects receiving a medical treatment or having a medical history of hepatitis 6) Subjects who have terrible anemia 7) Subjects who have addiction to alcohol 8) Subjects who need assistance by others and who cannot walk independently 9) Subjects who are bleeding (hemophilia, capillary vulnerability, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.) 10) Subjects who have the possibility of developing allergic symptoms by the test food 11) Subjects having a medical history of hypersensitivity to the test food 12) Subjects currently participating in other clinical trials or planning to participate in other clinical trials during the examination period 13) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 14) Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of markers of renal function (eGFR, creatinine)
- Secondary Outcome Measures
Name Time Method Changes of markers of renal function (creatinine clearance), Changes of markers relating to renal impairment (urinary L-FABP, albumin/creatinine, NAG, KIM-1, angiotensinogen), Changes of blood pressure, glucose metabolic markers (HbA1c, blood glucose), lipid markers (LDL-C, TG, HDL-C), body weight and other clinical test values