UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049845 |
|---|---|
| Receipt number | R000056780 |
| Scientific Title | Research on skin improvement by continuous intake of high-quality green tea (Matcha) - search for active ingredients |
| Date of disclosure of the study information | 2022/12/21 |
| Last modified on | 2022/12/21 09:28:31 |
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Basic information
Public title
Research on skin improvement by daily drinking of high-quality green tea (Matcha) - search for active ingredients
Acronym
Research on skin improvement by daily drinking of high-quality green tea (Matcha)
Scientific Title
Research on skin improvement by continuous intake of high-quality green tea (Matcha) - search for active ingredients
Scientific Title:Acronym
Research on skin improvement by continuous intake of high-quality green tea (Matcha)
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, subjects aged 20 to 75 who were employed as part-time workers were assigned to three groups and had them consume "high quality green tea (matcha)", "ordinary green tea (matcha)" and "placebo (colored starch)" for three months. Before and after, the condition of texture parameters (texture, sagging, brightness, redness, dullness, smoothness, etc.) is measured as the main purpose.
Basic objectives2
Others
Basic objectives -Others
As a secondary objective, blood, saliva, and urine will be collected to measure the content and metabolites of substances that may improve texture. The relationship between these indices and the improvement of texture is examined.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Twelve weeks after starting to drink the test food, the subject's skin condition is measured.
Key secondary outcomes
12 weeks after the start of intake of the test food, collect blood, saliva, and urine from the subjects. The content of matcha-containing substances that may improve texture is measured in blood, saliva, and urine collected.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects ingested 10g of "high-quality green tea (matcha)" daily for 90 days.
Interventions/Control_2
Subjects ingested 10g of "regular green tea (matcha)" daily for 90 days.
Interventions/Control_3
Subjects ingested 10g of "placebo (colored starch)" daily for 90 days.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 90 healthy adult males and females
(2) Persons who can obtain written consent from the individual to participate in the research voluntarily
(3) Persons aged 20 to 75 at the time of obtaining consent
(4) Gender: male and female
(5) Those who have applied for a part-time job
Key exclusion criteria
(1) Smoker
(2) Persons with serious illness
(3) Persons who are unable to enter information on a computer
(4) Those who are allergic to tea beverages, etc., or those who have had problems with caffeine beverages.
(5) Those who are pregnant or may become pregnant
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Watanabe |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Immunology
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5329
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
Department of Immunology
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5329
Homepage URL
e-w@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tea Industry Research Division,Kyoto Prefectural Agriculture,Forestry and Fisheries Technology Center,Agriculture and Forestry Technology Department
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
Medical Ethics Review Committee, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
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
| 2022 | Year | 12 | Month | 21 | 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
| 2022 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056780
