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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025146
Receipt No. 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

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Basic information
Public title Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial
Acronym Preliminary test of safety of oral ingestion of foods containing large amounts of carbon dioxide
Scientific Title Safety validation of oral ingestion of foods containing large amounts of carbon dioxide: a non-randomized, open-label, single-arm trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshiaki Inoue
Organization University of Tsukuba
Division name Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaragi, Japan
TEL 029-853-3210
Email yinoue@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ai Sato
Organization Kirin Company, Limited
Division name Beverages Laboratories, Research and Development Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 20 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028917

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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