UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041930 |
|---|---|
| Receipt number | R000047858 |
| Scientific Title | Analysis of the effect of matcha on preventing vascular aging and arteriosclerosis |
| Date of disclosure of the study information | 2020/09/29 |
| Last modified on | 2020/09/29 13:00:47 |
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Basic information
Public title
Analysis of the effect of matcha on preventing vascular aging and arteriosclerosis
Acronym
Analysis of the effect of matcha on preventing vascular aging and arteriosclerosis
Scientific Title
Analysis of the effect of matcha on preventing vascular aging and arteriosclerosis
Scientific Title:Acronym
Analysis of the effect of matcha on preventing vascular aging and arteriosclerosis
Region
| Japan |
Condition
Condition
Suspected arteriosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the mechanism of the vascular inflammation improving effect related to arteriosclerosis of polyamines by using high quality matcha and matcha for food processing having different contents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardio-ankle vascular index
Key secondary outcomes
1) Blood polyamine/ arginine concentration
2) Blood lipid/ carbohydrate/ insulin concentration
3) Mean and thickness in the maximum by carotid echo ( mean or max-IMT )
4) Skin age test using Aging Inspector (Verve, Kyoto, Japan)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Matcha (high quality) 2g/day 90days intake
Interventions/Control_2
Matcha (food processing) 2g/day 90days intake
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Patients with lifestyle-related diseases who tend to have arteriosclerosis while visiting the Department of Cardiology, Kyoto Prefectural University of Medicine (excluding patients with a diagnosis of arteriosclerosis)
2) Women
3) Age 40 years of age or older and 80 less than the age of the patient
4) Patients with consent
Key exclusion criteria
1) Patients who developed stroke / myocardial infarction within 1 year
2) Other patients who the researcher judges to be inappropriate as research subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoaki |
| Middle name | |
| Last name | Matoba |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular Medicine
Zip code
602-8566
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL
075-251-5511
matoba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Satoaki |
| Middle name | |
| Last name | Matoba |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular Medicine
Zip code
602-8566
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL
075-251-5511
Homepage URL
matoba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural Agriculture, Forestry and Fisheries Technology Center
Tea Industry Research Institute
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Cardiovascular Medicine
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
Tel
075-251-5511
matoba@koto.kpu-m.ac.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
| 2020 | Year | 09 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047858
| 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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| Registered date | File name |
