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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034209
Receipt No. R000039000
Scientific Title Study on work efficiency and fatigue improvement effect of green tea containing high theanine
Date of disclosure of the study information 2018/09/20
Last modified on 2019/03/22

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Basic information
Public title Study on work efficiency and fatigue improvement effect of green tea containing high theanine
Acronym Effect of green tea containing high theanine
Scientific Title Study on work efficiency and fatigue improvement effect of green tea containing high theanine
Scientific Title:Acronym Effect of green tea containing high theanine
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect on operation efficiency and fatigue of green tea beverage containing high theanine
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 Fatigue 60 minutes after drinking
(IgA, corticosterone, emotion)

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 Concentration 4% Green tea 150 ml

Single intake
Interventions/Control_2 Concentration 2% Green tea 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
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
2018 Year 09 Month 20 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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 20 Day
Date of IRB
2018 Year 11 Month 14 Day
Anticipated trial start date
2018 Year 12 Month 20 Day
Last follow-up date
2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 20 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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