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
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
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
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
