Unique ID issued by UMIN | UMIN000051358 |
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Receipt number | R000058590 |
Scientific Title | Safety overdose study of test food intake for healthy adults-Open-label study- |
Date of disclosure of the study information | 2023/06/16 |
Last modified on | 2023/06/16 14:25:45 |
Safety overdose study of test food intake for healthy adults
Safety overdose study of test food intake for healthy adults
Safety overdose study of test food intake for healthy adults-Open-label study-
Safety overdose study of test food intake for healthy adults-Open-label study-
Japan |
healthy adult
Adult |
Others
NO
Evaluate the safety of test foods
Safety
Adverse event
Physical examination
Laboratory test values
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Oral ingestion of the test food 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 foods 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 are going to the hospital for some illness or are being treated with drugs and Chinese medicine (as needed)
(9) Subjects who play intense sports and subjects who are on a diet
(10) Subjects with extremely irregular eating habits
(11) 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
(12) Subjects who drink more than 60 g of average daily pure alcohol
(13) Subjects who smoke an average of 21 or more cigarettes a day
(14) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(15) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
11
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal medicine
5300044
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
info@miura-cl.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
5300044
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
Kewpie Corporation
Profit organization
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
mterashima@miura-cl.jp
NO
医療法人花音会みうらクリニック(大阪府)
2023 | Year | 06 | Month | 16 | Day |
Unpublished
Preinitiation
2023 | Year | 04 | Month | 26 | Day |
2023 | Year | 05 | Month | 25 | Day |
2023 | Year | 06 | Month | 20 | Day |
2023 | Year | 07 | Month | 31 | Day |
2023 | Year | 06 | Month | 16 | Day |
2023 | Year | 06 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058590
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Research case data specifications | |
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Research case data | |
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