UMIN-ICDS Clinical Trial

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

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

Email

e-w@koto.kpu-m.ac.jp

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

Email

e-w@koto.kpu-m.ac.jp

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

Email

rinri@koto.kpu-m.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000056780