UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059186 |
|---|---|
| Receipt number | R000067675 |
| Scientific Title | Reexamination of the correlation between caffeine concentrations in blood and saliva |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/25 16:12:28 |
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Basic information
Public title
Reexamination of the correlation between caffeine concentrations in blood and saliva
Acronym
Reexamination of the correlation between caffeine concentrations in blood and saliva
Scientific Title
Reexamination of the correlation between caffeine concentrations in blood and saliva
Scientific Title:Acronym
Reexamination of the correlation between caffeine concentrations in blood and saliva
Region
| Japan |
Condition
Condition
Healthy adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the correlation between caffeine concentrations in blood and saliva when caffeine is ingested
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verification of the correlation between caffeine concentrations in blood and saliva
Key secondary outcomes
Individual differences in peak concentration time among caffeine drinking groups
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A beverage containing 150 mg of caffeine in 200 mL of water
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females aged 20 to 60 years
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | MASAKI |
| Middle name | |
| Last name | MOGI |
Organization
Graduate School of Medicine, Ehime University
Division name
Department of Pharmacology
Zip code
791-0295
Address
Shizukawa, Tohon, Ehime 791-0295, Japan
TEL
0899605260
mogi.masaki.me@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hosoki |
Organization
Glico Nutrition Co., Ltd.
Division name
R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
Homepage URL
yumi.hosogi@glico.com
Sponsor or person
Institute
Department of Pharmacology, Graduate School of Medicine, Ehime University
Institute
Department
Personal name
Funding Source
Organization
Glico Nutrition Co., Ltd.
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
Ehime University Clinical Research Review Committee
Address
Shizukawa, Tohon, Ehime 791-0295, Japan
Tel
089-960-5172
rinri@m.ehime-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
愛媛大学大学院医学系研究科薬理学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067675
