Unique ID issued by UMIN | UMIN000046691 |
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Receipt number | R000053256 |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: Open-label study |
Date of disclosure of the study information | 2023/03/21 |
Last modified on | 2022/01/21 12:34:52 |
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans:
Open-label study
A verification study of safety evaluation of excessive the test food consumption in humans:
Open-label study
Japan |
healthy individuals
Adult |
Others
NO
Evaluate safety by overdose (five times) the test food to the subject
Safety
Adverse event
Physical examination
Laboratory test values
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Ingestion of test food A for 4 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Subjects of men and women aged 20 to 64
(2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
(1) Subjects with heart, liver, and kidney diseases (including complications of other diseases)
(2) Subjects with a history of cardiovascular disease
(3) Subjects with diabetes
(4) Subjects with diseases currently being treated
(5) Subjects who are allergic to food and drugs
(6) Subjects with anemia symptoms
(7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects
(8) Subjects who play intense sports and subjects who are on a diet
(9) Subjects with extremely irregular eating habits
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who drink more than 60 g of average daily pure alcohol
(12) Subjects who smoke an average of 21 or more cigarettes a day
(13) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(14) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
20
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal Medicine
530-0044
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
0661355200
info@miura-cl.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
530-0044
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
0648018917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
Maruha Nichiro Corporation
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
0661355200
mterashima@miura-cl.jp
NO
医療法人花音会みうらクリニック(大阪府) Miura Clinic, Medical Corporation Kanonkai(Osaka)
2023 | Year | 03 | Month | 21 | Day |
Unpublished
Preinitiation
2022 | Year | 01 | Month | 20 | Day |
2022 | Year | 01 | Month | 20 | Day |
2022 | Year | 02 | Month | 04 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 01 | Month | 21 | Day |
2022 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053256
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