UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031212 |
|---|---|
| Receipt number | R000035641 |
| Scientific Title | Effectiveness of coffee on social communication: A randomized controlled trial. |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2018/07/21 09:53:05 |
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Basic information
Public title
Effectiveness of coffee on social communication: A randomized controlled trial.
Acronym
Effectiveness of coffee on social communication: A randomized controlled trial.
Scientific Title
Effectiveness of coffee on social communication: A randomized controlled trial.
Scientific Title:Acronym
Effectiveness of coffee on social communication: A randomized controlled trial.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the effectiveness of consuming coffee for activation of social communication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Rapport
Key secondary outcomes
Motivation to enhance a relationship
Affective state
Synchrony
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Consuming coffee
Interventions/Control_2
Consuming water
Interventions/Control_3
Not consuming anything
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criterion is daily consumption of coffee
Key exclusion criteria
none
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Fujiwara |
Organization
Osaka University of Economics
Division name
Faculty of Human Sciences
Zip code
Address
2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533
TEL
06-6328-2431
k.fujiwara1985@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Fujiwara |
Organization
Osaka University of Economics
Division name
Faculty of Human Sciences
Zip code
Address
2-2-8, Osumi, Higashiyodogawa-ku, Osaka, 533-8533
TEL
06-6328-2431
Homepage URL
k.fujiwara1985@gmail.com
Sponsor or person
Institute
Osaka University of Economics
Institute
Department
Personal name
Funding Source
Organization
Tobacco Academic Studies Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tobacco Academic Studies Center
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
大阪経済大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 09 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
use internet survey
Management information
Registered date
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2018 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035641
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
