Healthy volunteers
Conditions
Interventions
Intake of capsules (fish oil containing DHA) for 24 weeks
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Males between the ages of 45 and 74 years old 2) Subjects whose results at the screening examination fall into either of the following ? Systolic blood pressure >= 130 mmHg or diastolic blood pressure >= 85 mmHg ? Fasting blood glucose >= 110 mg/dL ? Spot urine albumin/creatinine >= 10 mg/g?Cr
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of markers of renal function (eGFR, creatinine) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed