UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024015 |
|---|---|
| Receipt number | R000027652 |
| Scientific Title | Placebo-controlled , double-blind, randomized controlled trials that verify effects of caffeine to university students' concentration |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2017/12/15 17:56:38 |
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Basic information
Public title
Placebo-controlled , double-blind, randomized controlled trials that verify effects of caffeine to university students' concentration
Acronym
caffeine trial for university students
Scientific Title
Placebo-controlled , double-blind, randomized controlled trials that verify effects of caffeine to university students' concentration
Scientific Title:Acronym
caffeine trial for university students
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify effect of caffeine to university students' concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy and speed of calculation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Regular Coffee 150ml, 1time
Interventions/Control_2
Decaf 150ml, 1time
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
University Students of Keio Univesity, School of Medicine
Key exclusion criteria
Subjetct who cannot drink or have not drunk coffee
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Takebayashi |
Organization
Keio University
Division name
School of Medicine
Zip code
Address
35 Shinanomachi, Shinjyuku-ku
TEL
0353633758
ayanotakeuchi@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayano Takeuchi |
Organization
Keio University
Division name
School of Medicine
Zip code
Address
35 Shinanomachi, Shinjyuku-ku
TEL
0353633758
Homepage URL
ayanotakeuchi@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 31 | 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
| 2018 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2017 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027652
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
