UMIN-CTR Clinical Trial

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
Institute	Central Research Institute, ITO EN, Ltd.
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048665