Unique ID issued by UMIN | UMIN000044005 |
---|---|
Receipt number | R000050252 |
Scientific Title | Effects of consumption of the test food on liver function: A randomized double-blind placebo-controlled trial |
Date of disclosure of the study information | 2021/04/22 |
Last modified on | 2022/08/10 16:51:35 |
Effects of consumption of the test food on liver function
Effects of consumption of the test food on liver function
Effects of consumption of the test food on liver function: A randomized double-blind placebo-controlled trial
Effects of consumption of the test food on liver function
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
Effects of consumption of supplements containing the plant-derived ingredient on the improvement of liver function
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The measured values of serum alanine aminotransferase (ALT) at 24 weeks after the start of test-food consumption (24w)
1. The measured values of serum ALT at four and 12 weeks after the start of test-food consumption (4w and 12w)
2. The change of serum ALT from screening (Scr) to after intervention (Scr to four weeks after the start of test-food consumption [4w], Scr to 12w, and Scr to 24w)
3. The change of serum ALT from before consumption (0w) to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w)
4. The measured values of serum asparate aminotransferase (AST), gamma-glutamyltranspeptidase (GT) and glutathione at 4w, 12w and 24w
5. The change of serum AST, gamma-GT and glutathione from Scr to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w)
6. The change of serum AST, gamma-GT and glutathione from 0w to after intervention (Scr to 4w, Scr to 12w, and Scr to 24w)
7. The ratio of number of subjects whose serum ALT at Scr is between 31 U/L or over and 40 U/L or under and whose serum ALT at 24w is 30 U/L or under, and subjects whose serum ALT at Scr is between 41 U/L or over and 50 U/L or under and whose serum ALT at 24w is 40 U/L or under
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Food |
Duration: 24 weeks
Test food: Supplements containing the plant-derived ingredient (the plant-derived ingredient 10 mg/capsule)
Administration: Take six capsules per day at after breakfast with approximately 100 mL of water
*If you forget to take the test food at after breakfast, take it as soon as you remember within the day.
Duration: 24 weeks
Test food: Placebo (without the plant-derived ingredient)
Administration: Take six capsules per day at after breakfast with approximately 100 mL of water
*If you forget to take the test food at after breakfast, take it as soon as you remember within the day.
45 | years-old | <= |
65 | years-old | > |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 45 or more and less than 65
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose serum ALT are 31U/L or more and 50U/L or under at Scr
7. Subjects whose serum AST are 50U/L or under at Scr
8. Subjects whose serum gamma-GT are 100U/L or under at Scr
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hepatitis B, hepatitis C, or any other chronic diseases
4. Subjects who have a habit of drinking an average of 60 g or more of pure alcohol per day on a weekly
5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
6. Subjects who currently taking medications (including herbal medicines) and supplements
7. Subjects allergic to medications and/or the test-food-related products. Particularly allergic to shrimp, crab, egg, wheat, soba (buckwheat), peanut, and milk
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who 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. Subjects who are judged as ineligible to participate in the study by the physician
74
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.
KAGOME CO.,LTD.
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)
2021 | Year | 04 | Month | 22 | Day |
Unpublished
Completed
2021 | Year | 04 | Month | 14 | Day |
2021 | Year | 04 | Month | 14 | Day |
2021 | Year | 04 | Month | 22 | Day |
2021 | Year | 12 | Month | 04 | Day |
2021 | Year | 04 | Month | 21 | Day |
2022 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050252
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |