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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036735
Receipt No. R000041855
Scientific Title 13C-caffeine breath test for the identification of single nucleotide polymorphisms associated with caffeine metabolism
Date of disclosure of the study information 2019/05/15
Last modified on 2019/06/03

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Basic information
Public title 13C-caffeine breath test for the identification of single nucleotide polymorphisms associated with caffeine metabolism
Acronym 13C-caffeine breath test for the identification of single nucleotide polymorphisms associated with caffeine metabolism
Scientific Title 13C-caffeine breath test for the identification of single nucleotide polymorphisms associated with caffeine metabolism
Scientific Title:Acronym 13C-caffeine breath test for the identification of single nucleotide polymorphisms associated with caffeine metabolism
Region
Japan

Condition
Condition none
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We performed caffeine (N-3-methyl-13C) breath test (CafeBT) to determine whether it can be used to identify SNPs (CYP1A2, aryl-hydrocarbon receptor, adenosine A2A receptor) that are associated with caffeine metabolism.
Basic objectives2 Others
Basic objectives -Others 4 SNPs (rs762551, rs2472297, rs4410790, and rs5751876) in the AUC of the breath 13CO2 to evaluate whether it can be identified.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 4 SNPs (rs762551, rs2472297, rs4410790, and rs5751876) in the AUC of the breath 13CO2 to evaluate whether it can be identified.
Key secondary outcomes

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
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 N-3-methyl-13C caffeine
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
40 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria none
Target sample size 450

Research contact person
Name of lead principal investigator
1st name YUKIMOTO
Middle name
Last name ISHII
Organization Nihon University School of Medicine
Division name Division of Research Planning and Development, Medical Research Support Center
Zip code 173-8610
Address Ohyaguchi 30-1, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email ishii.yukimoto@nihon-u.ac.jp

Public contact
Name of contact person
1st name YUKIMOTO
Middle name
Last name ISHII
Organization Nihon University School of Medicine
Division name Division of Research Planning and Development, Medical Research Support Center
Zip code 173-8610
Address Ohyaguchi 30-1, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email ishii.yukimoto@nihon-u.ac.jp

Sponsor
Institute Division of Research Planning and Development, Medical Research Support Center, Nihon University School of Medicine.
Institute
Department

Funding Source
Organization Division of Research Planning and Development, Medical Research Support Center, Nihon University School of Medicine.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nihon University School of Medicine, Ethics Committee
Address Ohyaguchi 30-1, Itabashi-ku, Tokyo, Japan
Tel 0339728111
Email med.kenjimu@nihon-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 15 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 Enrolling by invitation
Date of protocol fixation
2009 Year 08 Month 22 Day
Date of IRB
2017 Year 08 Month 22 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 14 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041855

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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