UMIN-CTR Clinical Trial

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
Email	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
Email	matoba@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047858