UMIN-CTR Clinical Trial

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	35
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 09 Month 20 Day

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