UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029049
Receipt number R000033227
Scientific Title Effects of aroma compounds in coffee on its flavor and relaxation and concentration in humans.
Date of disclosure of the study information 2017/09/08
Last modified on 2020/03/30 12:36:34

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Basic information

Public title

Effects of aroma compounds in coffee on its flavor and relaxation and concentration in humans.

Acronym

Coffee aroma and stress index

Scientific Title

Effects of aroma compounds in coffee on its flavor and relaxation and concentration in humans.

Scientific Title:Acronym

Coffee aroma and stress index

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal which of aroma compounds in coffee increases relaxation or concentration.

Basic objectives2

Others

Basic objectives -Others

Physiological response

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Continuous addition test.
Measure before and after test: salivary amylase activity, blood pressure, and pulse rate.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Performs a continuous addition test
Intervention period: for 15 min.

Sniff a cup of coffee that is flavored with an aroma constituent (an off-flavor component) before and every 5 min during the test.

Interventions/Control_2

Performs a continuous addition test
Intervention period: for 15 min.

Sniff a cup of coffee that is flavored with another aroma constituent (such as furfuryl compound) before and every 5 min during the test.

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

18 years-old <=

Age-upper limit

29 years-old >=

Gender

Male and Female

Key inclusion criteria

Students of the University of Niigata Prefecture

Key exclusion criteria

Persons who cannot drink coffee.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shin
Middle name
Last name Kamiyama

Organization

Faculty of Human Life Studies, University of Niigata Prefecture

Division name

Department of Health and Nutrition

Zip code

950-8680

Address

471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan

TEL

025-368-8269

Email

kammy@unii.ac.jp


Public contact

Name of contact person

1st name Shin
Middle name
Last name Kamiyama

Organization

Faculty of Human Life Studies, University of Niigata Prefecture

Division name

Department of Health and Nutrition

Zip code

950-8680

Address

471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan

TEL

025-368-8269

Homepage URL


Email

kammy@unii.ac.jp


Sponsor or person

Institute

University of Niigata Prefecture

Institute

Department

Personal name



Funding Source

Organization

University of Niigata Prefecture

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Niigata Prefecture

Address

471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan

Tel

025-270-1300

Email

unp@unii.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

2017 Year 09 Month 08 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

30

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Preparing a report for publication

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

2017 Year 07 Month 10 Day

Date of IRB

2017 Year 07 Month 25 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2018 Year 01 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

2017 Year 09 Month 07 Day

Last modified on

2020 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033227


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name