Unique ID issued by UMIN | UMIN000029483 |
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Receipt number | R000033686 |
Scientific Title | Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, single-arm, open-label trial |
Date of disclosure of the study information | 2017/10/10 |
Last modified on | 2018/02/27 11:46:53 |
Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, single-arm, open-label trial
Safety test 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, single-arm, open-label trial
Safety test of oral ingestion of foods containing large amounts of carbon dioxide
Japan |
No
Adult |
Others
NO
This study aimed to confirm the safety of carbon dioxide-rich food by examining the effects on the respiratory and circulatory systems.
Safety
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
Self control
1
Prevention
Food |
Within 1 day, a participant ingests one type of test food that contains large amounts of carbon dioxide. A participant ingests 0.5 g, 2.5 g and 4.5 g of test foods in turn.
a participant ingests one type of control food that contains no carbon dioxide. A participant ingests 4.5 g of control foods.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
(1) Male and female subjects aged 20-65 years old 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 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 asthma
(4) Have a disease of the respiratory system affecting exams
(5) Have a disease and/or previous history of heart disease
(6) Have a serious disorder and/or chronic disorder such as hyperlipidemia, diabetes, and/or a disease of the kidneys or liver
(7) Are pregnant, or are planning to become pregnant
(8) Are participating in other clinical studies on medicine, cosmetics, or food
(9) Are for other reasons deemed by the principal investigator as unsuitable for this study
20
1st name | |
Middle name | |
Last name | Yoshiaki Inoue |
University of Tsukuba
Emergency and Critical Care Medicine, Faculty of Medicine
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
+81-29-853-3210
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
+81-80-2990-3796
Ai_sato@kirin.co.jp
Kirin Company, Limited
Kirin Company, Limited
Profit organization
NO
国立大学法人 筑波大学(茨城県)/ University of Tsukuba (Ibaraki)
2017 | Year | 10 | Month | 10 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 20 | Day |
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 10 | Month | 10 | Day |
2018 | Year | 02 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033686
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