Unique ID issued by UMIN | UMIN000049881 |
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Receipt number | R000056797 |
Scientific Title | A verification study of the protection and improvement effects of the test food on kidney function: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/10/15 |
Last modified on | 2024/03/15 10:14:22 |
A verification study of the protection and improvement effects of the test food on kidney function
A verification study of the protection and improvement effects of the test food on kidney function
A verification study of the protection and improvement effects of the test food on kidney function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study of the protection and improvement effects of the test food on kidney function
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the protection and improvement effects of the test food on kidney function
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The calculated values of the creatinine-based estimated glomerular filtration rate (eGFRcreat) at 24 weeks after consumption (24w)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
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 you do not eat a meal, take the test foods at any time.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 24 weeks
Test food: Soybean oil capsule
Administration: Take four capsules after each meal. In total 12 capsules a day, taken three times daily. If you do not eat a meal, take the test foods at any time.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
45 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
76
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Maruha Nichiro Corporation
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2023 | Year | 10 | Month | 15 | Day |
Unpublished
84
Completed
2022 | Year | 12 | Month | 14 | Day |
2022 | Year | 12 | Month | 14 | Day |
2022 | Year | 12 | Month | 23 | Day |
2023 | Year | 10 | Month | 15 | Day |
2022 | Year | 12 | Month | 23 | Day |
2024 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056797
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