UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042647
Receipt number R000048665
Scientific Title A pharmacokinetics study of catechins
Date of disclosure of the study information 2020/12/06
Last modified on 2021/12/06 08:40:49

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Basic information

Public title

A pharmacokinetics study of green tea catechins after ingestion of green tea beverage

Acronym

A pharmacokinetics study of catechins

Scientific Title

A pharmacokinetics study of catechins

Scientific Title:Acronym

A pharmacokinetics study of green tea catechins after ingestion of green tea beverage

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the pharmacokinetics of catechins

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Pharmacokinetics and metabolism of ingested catechins

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of green tea beverage

Interventions/Control_2


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

40 years-old >

Gender

Male

Key inclusion criteria

(1)Males whose age are 20<=years old<40.
(2)Subjects who are between 18.5 kg/m2 or more and less than 25.0 kg/m2 in BMI.
(3)Subjects who are judged to be suitable for the test by the investigator.

Key exclusion criteria

(1)Subjects who are with treatment at the time of Advance inspection.
(2)Subjects who have severe anemia.
(3)Subjects whose blood test values are outside of the reference range at the time of Advance inspection.
However this is not applicable to the subjects who are deemed to be able to participate in the test by the investigator.
(4)Subjects who are with allergy to the study foods or meals during the hospital stay.
(5)Subjects who are with current or past medical history of gastrointestinal disease, cardiovascular disease, nephritis and others. Subjects who are with severe mental disorder.
(6) Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test at the time of Advance inspection.
(7)Subjects who cannot stop smoking during the hospital stay.
(8)Subjects who took the OTC (including the oriental medicines), the Foods with health claims (Foods for specified health uses and others), the health foods, the supplements and others regularly within the past 1 month at the time of Advance inspection.
(9)Subjects who have potential to change the lifestyle in the test period.
(10) Subjects who donated 200mL of blood within the past 1 month or 400mL of blood within the past 3 months at the time of Advance inspection.
(11)Subjects who are attending other studies or attended other studies within the past 3 months.
(12)Subjects who are judged to be unsuitable for the test by the investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Takazawa

Organization

Shinanozaka Clinic

Division name

Director of a clinic

Zip code

160-0017

Address

Yotsuya Medical Building 3F, 20 Samon-cho, Shinjuku-ku, Tokyo

TEL

0353663006

Email

takazawa@shinanokai.com


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Kobayashi

Organization

ITO EN, Ltd.

Division name

Central Research Institute

Zip code

421-0516

Address

21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan

TEL

0548541247

Homepage URL


Email

m-kobayasi@itoen.co.jp


Sponsor or person

Institute

Central Research Institute, ITO EN, Ltd.

Institute

Department

Personal name



Funding Source

Organization

ITO EN, Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinanozaka Clinic Ethics Committee

Address

Yotsuya Medical Building 3F, 20 Samon-cho, Shinjuku-ku, Tokyo

Tel

0353663006

Email

m-iwasaki@shinanokai.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



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 06 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

Completed

Date of protocol fixation

2020 Year 11 Month 12 Day

Date of IRB

2020 Year 11 Month 25 Day

Anticipated trial start date

2020 Year 12 Month 06 Day

Last follow-up date

2020 Year 12 Month 15 Day

Date of closure to data entry

2021 Year 12 Month 29 Day

Date trial data considered complete

2022 Year 01 Month 29 Day

Date analysis concluded

2022 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2020 Year 12 Month 04 Day

Last modified on

2021 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048665


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name