UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on the effects of green tea components on sleep and stress
Acronym	Clinical study on the effects of green tea components on sleep and stress
Scientific Title	Clinical study on the effects of green tea components on sleep and stress
Scientific Title:Acronym	Clinical study on the effects of green tea components on sleep and stress
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of different ratios of caffeine, epigallocatechin gallate, theanine and arginine in green tea on stress reduction and sleep.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain waves in sleep
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	General green tea.
Interventions/Control_2	Green tea including low caffeine.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Being at least 20 years old when obtaining informed consent (2)Able to take green tea (3)Able to collect saliva (4)Able to collect information by a wearable activity tracker (wristwatch style) (5)Obtained written informed consent from subjects
Key exclusion criteria	(1)Subjects taking drugs that affect sleep such as stimulants (diethylpropion, epinephrine), sleep inducing drug and antianxiety drugs (etizolam, diazepam) (2)Subjects who take beverages containing caffein or theanine such as green tea, coffee, coke and energy drink from Monday to Friday during the study (3)Subjects diagnosed by physicians inappropriate to participate in the study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Furushima
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	0542645102
Email	dfuru@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Furushima
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	0542645102
Homepage URL
Email	dfuru@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	University of Shizuoka
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 Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel	0542645102
Email	dfuru@u-shizuoka-ken.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	2021 Year 11 Month 18 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	Enrolling by invitation
Date of protocol fixation	2021 Year 10 Month 15 Day
Date of IRB	2021 Year 10 Month 15 Day
Anticipated trial start date	2021 Year 11 Month 15 Day
Last follow-up date	2021 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 18 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052588