UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036735 |
|---|---|
| Receipt number | 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 | 2022/11/18 10:04:13 |
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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 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
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
ishii.yukimoto@nihon-u.ac.jp
Sponsor or person
Institute
Division of Research Planning and Development, Medical Research Support Center, Nihon University School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041855
