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

Email

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


Email

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


Email



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
Registered date File name

Research case data
Registered date File name