UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040022 |
|---|---|
| Receipt number | R000045628 |
| Scientific Title | An open label study of the elevation of plasma catechin concentration |
| Date of disclosure of the study information | 2020/04/03 |
| Last modified on | 2022/10/03 10:01:09 |
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Basic information
Public title
An open label study of the elevation of plasma catechin concentration
Acronym
An open label study of the elevation of plasma catechin concentration
Scientific Title
An open label study of the elevation of plasma catechin concentration
Scientific Title:Acronym
An open label study of the elevation of plasma catechin concentration
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the causes of individual differences in plasma catechin concentrations by using a preliminary genome-wide association study
Basic objectives2
Others
Basic objectives -Others
SNPs associated with plasma catechin concentration after ingestion of catechins.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma catechin concentration
Key secondary outcomes
SNPs associated with plasma catechin concentration
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
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Single oral dose of green tea catechins in a fasting state
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects are competent to consent, keep the rules of the study
2. Subjects who are judged by the physician as eligible to participate in the trial
Key exclusion criteria
. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake
5. Subjects regularly taking medications (including herbal medicines) and supplements
6. Subjects allergic to medications and/or the test-food-related products
7. Subjects who are pregnant, lactating, or intending to become pregnan
8. Subjects who participated in other clinical tests in 3 months before a consent form acquisition day or who are planning to participate in the test duration
9. Subjects who are judged by the physician as ineligible to participate in the trial
Target sample size
80
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
0548-54-1247
m-kobayasi@itoen.co.jp
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, Japan
TEL
0548-54-1247
Homepage URL
m-kobayasi@itoen.co.jp
Sponsor or person
Institute
Central Research Institute, ITO EN, Ltd
Institute
Department
Personal name
Funding Source
Organization
Central Research Institute, 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
Ethical review committee
Address
3-47-10 Honmachi, shibuya-ku, Tokyo
Tel
03-5371-7195
k-murayama@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
医療法人社団盛心会タカラクリニック
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 03 | 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
69
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Recruiting and conducting has been suspended by communicable disease (COVID-19)in Japan
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 | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045628
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