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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name