UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046109 |
|---|---|
| Receipt number | 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 15:18:44 |
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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
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
dfuru@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052588
