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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046109
Receipt No. R000052588
Scientific Title Clinical study on the effects of green tea components on sleep and stress
Date of disclosure of the study information 2021/11/18
Last modified on 2021/11/18

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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

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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