UMIN-CTR Clinical Trial

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 13C-caffeine 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 100mg caffeine 13C3 (trimethyl-13C3) 100mg N-1-methyl-13C caffeine 100mg
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	Healthy adults
Key exclusion criteria	none
Target sample size	600

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	Japan

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 31 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 14 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041855