UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial
Title of the study (Brief title)	Preliminary test of safety of oral ingestion of foods containing large amounts of carbon dioxide
Region	Japan

Condition
Condition	No
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	End-tidal carbon dioxide partial pressure
Key secondary outcomes	Pulse oximeter oxygen saturation, Electrocardiogram, Heart rate, Blood pressure, Respiratory rate, Thoracic motion

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(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
Key exclusion criteria	(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
Target sample size	5

Research contact person
Name of lead principal investigator	Yoshiaki Inoue
Organization	University of Tsukuba
Division name	Emergency and Critical Care Medicine, Faculty of Medicine
Address	1-1-1, Tennodai, Tsukuba, Ibaragi, Japan
TEL	029-853-3210
Email	yinoue@md.tsukuba.ac.jp

Public contact
Name of contact person	Ai Sato
Organization	Kirin Company, Limited
Division name	Beverages Laboratories, Research and Development Division
Address	1-17-1, Namamugi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL	080-2990-3796
Homepage URL
Email	Ai_sato@kirin.co.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Kirin Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立大学法人　筑波大学（茨城県）/ University of Tsukuba (Ibaragi)

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 20 Day
Anticipated trial start date	2016 Year 12 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 05 Day
Last modified on	2017 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028917