UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037886
Receipt number R000043192
Scientific Title Study on influence of a Japanese traditional tea of Matcha ingestion on work efficiency and fatigue.
Date of disclosure of the study information 2019/09/02
Last modified on 2019/09/20 09:51:58

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Basic information

Public title

Study on influence of a Japanese traditional tea of Matcha ingestion on work efficiency and fatigue.

Acronym

Study on influence of a Japanese traditional tea of Matcha ingestion on mind and body.

Scientific Title

Study on influence of a Japanese traditional tea of Matcha ingestion on work efficiency and fatigue.

Scientific Title:Acronym

Study on influence of a Japanese traditional tea of Matcha ingestion on mind and body.

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study influence of Matcha ingestion on operation efficiency and fatigue.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Work efficiency for 60 minutes after drinking
(Score of personal computer work, EEG, heart rate variability)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Matcha (high quality) 150 ml

Single intake

Interventions/Control_2

Matcha (low quality) 150 ml

Single intake

Interventions/Control_3

Water 150 ml

Single intake

Interventions/Control_4

Theanine-containing water 150 ml

Single intake

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

30 years-old >

Gender

Male

Key inclusion criteria

1) Healthy college student, Graduate student
2) Person who can acquire the consent of research participation by voluntary intention from himself in writing
3) Patients who aged 20 to over 30 when their ages were acquired
4) Male
5) Those who applied for recruitment as a part-time job and who applied for volunteers

Key exclusion criteria

1) smoker
2) Persons with severe disease
3) Person who can not do personal computer work
4) Persons who have an allergic reaction in tea

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Eri
Middle name
Last name Watanabe

Organization

Kyoto Prefectural University of Medicine

Division name

Immunology

Zip code

602-8566

Address

Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.

TEL

0752515329

Email

e-w@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Eri
Middle name
Last name Watanabe

Organization

Kyoto Prefectural University of Medicine

Division name

Immunology

Zip code

6028566

Address

Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.

TEL

0752515329

Homepage URL


Email

e-w@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural Agriculture, Forestry and Fisheries Technology Center
Tea Industry Research Institute

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine Medical Ethics Review Committee

Address

Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.

Tel

075-251-5337

Email

rinri@koto.kpu-m.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

2019 Year 09 Month 02 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

2019 Year 09 Month 02 Day

Date of IRB

2019 Year 11 Month 26 Day

Anticipated trial start date

2019 Year 09 Month 02 Day

Last follow-up date

2020 Year 09 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 02 Day

Last modified on

2019 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043192


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name