UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052887 |
|---|---|
| Receipt number | R000060180 |
| Scientific Title | A comparative study of metabolism of catechins after ingestion of the beverage with different catechins compositions |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/24 09:35:22 |
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Basic information
Public title
A comparative study of metabolism of catechins after ingestion of the beverage with different catechins compositions
Acronym
A comparative study of metabolism of catechins
Scientific Title
A comparative study of metabolism of catechins after ingestion of the beverage with different catechins compositions
Scientific Title:Acronym
A comparative study of metabolism of catechins
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 absorption and metabolism of catechins.
Basic objectives2
PK,PD
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
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of the beverage with catechins A
Interventions/Control_2
Single ingestion of the beverage with catechins B
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Males and Females whose age are 18<=years old<60 and who work at Production Headquarters, ITOEN, LTD
Key exclusion criteria
(1) Subjects who are with treatment.
(2) Subjects who have severe anemia.
(3) Subjects who are with allergy to the study foods or meals in the test period.
(4) Subjects who are with current or past medical history of gastrointestinal disease, cardiovascular disease, nephritis and others. Subjects who are with severe mental disorder.
(5) Subjects who have potential to change the lifestyle in the test period.
(6) Smokers.
(7) Subjects who regularly intake foods for specified health uses or foods with functional claims.
(8) Subjects who regularly intake pharmaceuticals including oriental medicines or dietary supplements.
(9) Subjects who are with allergy to pharmaceuticals or foods related to the study foods.
(10) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period.
(11) Subjects who are judged to be unsuitable for the test by the medical doctor for the other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 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, Japan
TEL
0548541247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Shuto |
| Middle name | |
| Last name | Tsunemi |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL
0548541247
Homepage URL
s-tsunemi@itoen.co.jp
Sponsor or person
Institute
Central Research Institute, ITO EN, Ltd
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Laboratory of Food Function Analysis, Graduate School of Agricultural Science, Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ITO EN, Ltd. Institutional review board
Address
Hon-machi, Shibuya-ku, Tokyo
Tel
03-5371-7111
t-okano@itoen.co.jp
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
| 2023 | Year | 12 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060180
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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