UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000025146
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

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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

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

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

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No need to know

Intervention

No. of arms

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

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 or person

Institute

University of Tsukuba

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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