UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043122 |
|---|---|
| Receipt number | R000049230 |
| Scientific Title | Study to verify the effect of green tea-derived components to physical condition |
| Date of disclosure of the study information | 2021/02/05 |
| Last modified on | 2021/01/25 14:27:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A double-blind, parallel-group comparative study examining the effectiveness of green tea-derived components for physical condition in winter
Acronym
A double-blind, parallel-group comparative study examining the effectiveness of green tea-derived components for physical condition in winter
Scientific Title
Study to verify the effect of green tea-derived components to physical condition
Scientific Title:Acronym
A double-blind, parallel-group comparative study examining the effectiveness of green tea-derived components for physical condition in winter
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of green tea-derived components -containing beverage intake for physical condition in winter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of events that reduce physical condition when taking continuously for 12 weeks
Key secondary outcomes
Each evaluation item using GHQ60 when taking continuously for 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12 weeks,
Placebo drink,
once a day
Interventions/Control_2
12 weeks,
Active drink, including green tea-derived components,
once a day
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Subjects
Key exclusion criteria
-Those who may develop seasonal allergic symptoms such as pollinosis during the test period and may use medicines
-Those who are currently suffering from chronic diseases and receiving drug treatment
-Those who may show allergic symptoms to the test food or those who may show allergic symptoms to tea and the ingredients contained in tea (catechin, theanine, caffeine)
-Those who are pregnant or may become pregnant
-Those who have difficulty in participating in the study due to liver / kidney / heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neuropathy, consciousness disorder, diabetes, and other diseases.
-Those who consume excessive alcohol (more than 60g/d)
-Those who are participating in other human tests
-Those infected with SARS-COV-2
-Those who do not work daily (those who have night rotation work)
-Other persons who are judged by the investigator to be inappropriate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kusaura |
Organization
Kao Corporation
Division name
Health & Wellness Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-7441
kusaura.tatsuya@kao.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kusaura |
Organization
Kao Corporation
Division name
Health & Wellness Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
03-5630-7441
Homepage URL
kusaura.tatsuya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
うえのあさがおクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 10 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049230
