UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the correlation between blood arginase level and vascular endothelial function and arterial stiffness in healthy adults.
Acronym	Examination of the correlation between blood arginase level and vascular function.
Scientific Title	Examination of the correlation between blood arginase level and vascular endothelial function and arterial stiffness in healthy adults.
Scientific Title:Acronym	Examination of the correlation between blood arginase level and vascular function.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the relationship between blood arginase-related factors and the vascular function including vascular endothelial function and arterial stiffness in healthy adults.
Basic objectives2	Others
Basic objectives -Others	The relationship between blood arginase-related factors and the vascular function including vascular endothelial function and arterial stiffness will be evaluated by a cross-sectional study.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood arginase level Vascular function
Key secondary outcomes	1. Vascular aging 2. Blood analysis 3. Physical measurement 4. Physical examination 5. Stress evaluation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	45 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy subjects who meet the following criteria (1) Subjects aged from 40 to 70 years old: Women are limited to postmenopausal (Duration of amenorrhea; >1 y) (2) Subjects whose blood pressure is within the normal high value (139 mmHg >=SBP or/and 89 mmHg >=DBP) (3) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and are able to provide a written informed consent.
Key exclusion criteria	(1) Subjects who have the history of heart disease, liver disease, kidney disease, respiratory disease, endocrine disease, metabolic disease, or the history of these diseases. (2) Subjects who have the disease under treatment. (3) Subjects who regularly use supplements, health food (including foods for specified health use / foods with functional claims) during the test period. (4) Subjects who take part in another clinical study during the study. (5) Subjects who are excessively take alcohol (expressed in an amount of alcohol: over 20g/day). (6) Subjects who have a smoking habit (those who smoke daily or occasionally in the last 3 months) (7) Subjects who conduct hormone replacement therapy in the 3 months. (8) Asthma patients (9) Subjects who regularly exercise (> 120 min / week) (10) Subjects who are judged by the investigator to be inappropriate as subjects based on the test results at the time of screening (11) Subjects deemed unsuitable by the investigator for other reasons
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Morita
Organization	Kirin Holdings Company, Limited
Division name	Research & Development Division, KIRIN Central Research Institute
Zip code	305-0841
Address	2, Miyukigaoka, Tsukuba-shi, Ibaraki, Japan
TEL	090-3063-2127
Email	Masahiko_Morita@kirin.co.jp

Public contact
Name of contact person	1st name Masakazu Middle name Last name Tomaru
Organization	Synapse Planning Company, Limited.
Division name	Clinical Trial Session
Zip code	162-0054
Address	5-45-1, Higashinippori, Arakawa-ku, Tokyo, Japan
TEL	03-5604-9442
Homepage URL
Email	tomaru@synaps.co.jp

Sponsor
Institute	Kirin Holdings Company, Limited
Institute
Department

Funding Source
Organization	Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional review board of Tsukiji Futaba Clinic
Address	Hosokawa Tsukiji Bild. 6th Floor, Tsukiji 1-9-9, Cyuou-ku Tokyo
Tel	03-6226-5812
Email	tohru@hikobae.net

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	東京シーサイドクリニック、医療法人社団成守会　はせがわ病院

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 24 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	124
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	2021 Year 06 Month 30 Day
Date of IRB	2021 Year 06 Month 30 Day
Anticipated trial start date	2021 Year 09 Month 25 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 06 Month 22 Day

Other

Other related information

It has been suggested that blood arginase level in healthy adults may be an early diagnostic marker for arteriosclerosis as well as cardiovascular risks, but no detailed studies have been conducted. Therefore, the purpose of this study is to clarify the relationship between blood arginase level and vascular function including vascular endothelial function and arterial stiffness, which more directly reflects the early stage of arteriosclerosis, in healthy adults.

Management information
Registered date	2021 Year 09 Month 22 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051981