Unique ID issued by UMIN | UMIN000025146 |
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Receipt number | R000028917 |
Scientific Title | Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/06/06 09:17:40 |
Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial
Preliminary test of safety of oral ingestion of foods containing large amounts of carbon dioxide
Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial
Preliminary test of safety of oral ingestion of foods containing large amounts of carbon dioxide
Japan |
No
Not applicable | Adult |
Others
NO
This study aimed to evaluate what amount of carbon dioxide-rich food is safe for human consumption, by examining the effects on the respiratory and circulatory systems.
Safety
Exploratory
Not applicable
End-tidal carbon dioxide partial pressure
Pulse oximeter oxygen saturation, Electrocardiogram, Heart rate, Blood pressure, Respiratory rate, Thoracic motion
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Prevention
Food |
Within 1 day, a participant ingests three different types of test foods that contain large amounts of carbon dioxide. Individual test food servings are 0.5-10 g.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Male and female subjects aged 20-64 years old and who give written informed consent
(2) Give written informed consent after receiving sufficient explanation of the study purpose and details, thoroughly understand the study, and of their own free will decide to participate
(1) End-tidal carbon dioxide partial pressure is >46 mmHg at the time of the screening test
(2) Are deemed unsuitable based on screening tests concerning the circulatory system
(3) Have a disease of the respiratory system
(4) Have a disease and/or previous history of disease of the heart
(5) Have a serious disorder and/or chronic disorder such as hyperlipidemia, diabetes, and/or a disease of the kidneys or liver
(6) Are participating in other clinical studies on medicine, cosmetics, or food
(7) Are for other reasons deemed by the principal investigator as unsuitable for this study
5
1st name | |
Middle name | |
Last name | Yoshiaki Inoue |
University of Tsukuba
Emergency and Critical Care Medicine, Faculty of Medicine
1-1-1, Tennodai, Tsukuba, Ibaragi, Japan
029-853-3210
yinoue@md.tsukuba.ac.jp
1st name | |
Middle name | |
Last name | Ai Sato |
Kirin Company, Limited
Beverages Laboratories, Research and Development Division
1-17-1, Namamugi, Tsurumi-ku, Yokohama, Kanagawa, Japan
080-2990-3796
Ai_sato@kirin.co.jp
University of Tsukuba
Kirin Company, Limited
Profit organization
NO
国立大学法人 筑波大学(茨城県)/ University of Tsukuba (Ibaragi)
2017 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 20 | Day |
2016 | Year | 12 | Month | 12 | Day |
2017 | Year | 04 | Month | 01 | Day |
2016 | Year | 12 | Month | 05 | Day |
2017 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028917
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