Unique ID issued by UMIN | UMIN000041495 |
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Receipt number | R000047022 |
Scientific Title | Safety confirmation test of collagen-containing food |
Date of disclosure of the study information | 2021/08/15 |
Last modified on | 2021/08/23 10:57:59 |
Safety confirmation test of collagen-containing food
Safety confirmation test of collagen-containing food
Safety confirmation test of collagen-containing food
Safety confirmation test of collagen-containing food
Japan |
N/A (healthy adults)
Adult |
Others
NO
To evaluate the safety of excessive consumption of collagen-containing food
Safety
Doctor's questions, Physiological test, Clinical examination, Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Collagen-containing food, 4 weeks excessive consumption
20 | years-old | <= |
74 | years-old | >= |
Male and Female
(1)Healthy adult males and females aged 20 to 74 years-old
(2)Those whose written informed consent have been obtained
(1)Those who have a history of diabetes, liver disease, kidney disease, digestive system disease, heart disease, or other diseases that may affect the results of this test, or who have had a history of surgery
(2)Those with abnormal liver and renal function test values
(3)Those who have a disease currently being treated
(4)Those with anemia
(5)Those who detect abnormal values by blood test
(6)Those with food and drug allergies
(7)Those who play intense sports and who are on a diet
(8)Those who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and designated quasi-drugs during the test period
(9)Those who continuously take medicines (including OTC and prescription medicines)
(10)Those who have taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
(11)Heavy drinkers, or those who can't stop drinking from the day before the test until the day
(12)Those who have smoking habits
(13)Those with irregular life patterns and with lifestyle of reversal of day and night
(14)Those who have habits of excessive eating and drinking
(15)Those who have been pregnant or those who have a plan to become pregnant or breast feed during the study period
(16)Those who are participating in or will be participating in other clinical trials at the start of this study, and those within 4 weeks after the end
(17)Those who judged that examination responsible doctor is not appropriate for this study participation
22
1st name | Yoshiaki |
Middle name | |
Last name | Shiojima |
Ryusendo Co., Ltd.
President and CEO
171-0021
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
03-3985-8346
y.shiojima@ryusendo.co.jp
1st name | Megumi |
Middle name | |
Last name | Takahashi |
Ryusendo Co., Ltd.
Development Division
171-0021
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
03-3985-8346
m.takahashi@ryusendo.co.jp
Oneness support Co., Ltd.
Ryusendo Co., Ltd.
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka 530-0044, Japan
06-6135-5200
mterashima@miura-cl.jp
NO
2021 | Year | 08 | Month | 15 | Day |
Unpublished
22
Completed
2020 | Year | 08 | Month | 03 | Day |
2020 | Year | 08 | Month | 20 | Day |
2020 | Year | 09 | Month | 18 | Day |
2020 | Year | 11 | Month | 13 | Day |
2020 | Year | 08 | Month | 21 | Day |
2021 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047022
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Research case data specifications | |
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Research case data | |
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