UMIN-CTR Clinical Trial

Basic information
Public title	The CHIRAN TEA/Folic acid supplement project
Acronym	The CHIRAN TEA/Folic acid supplement project
Scientific Title	Health promotion measures with a dietary supplement containing catechin and folic acid among Japanese adults: The CHIRAN TEA/Folic acid supplement project.
Scientific Title:Acronym	The CHIRAN TEA/Folic acid supplement project
Region	Japan

Condition
Condition	Health promotion
Classification by specialty	Geriatrics Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this project is health promotion with a dietary supplement containing folic acid and green tea catechin among Japanese adults.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Health related QOL
Key secondary outcomes	The compliance of dietary supplements. The prevalence of new-onset dementia, cerebral infarction and other diseases associated with high homocysteine and/or low folate. Changes in medical costs. The changes in plasma folic acid and homocysteine.

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	Prevention
Type of intervention	Food
Interventions/Control_1	Administration of dietary supplements containing folic acid (400 microgram) and catechin (150 mg) for one year.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- Age: more than or equal to 65 years at the time of providing informed consent - Individuals who have never experienced psychological and critical diseases. - Individuals who have the ability to provide written informed consent.
Key exclusion criteria	- Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs. - Subjects judged to be inappropriate for the study by the investigator.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Seika Middle name Last name Kamohara
Organization	DHC Corporation
Division name	Division of Research Adviser
Zip code	106-0047
Address	MIC-Bldg 6F, Minami-azabu 2-8-21, Minato-ku, Tokyo
TEL	03-6845-0166
Email	kamohara-seika@umin.ac.jp

Public contact
Name of contact person	1st name Seika Middle name Last name Kamohara
Organization	DHC Corporation
Division name	Division of Research Adviser
Zip code	106-0047
Address	MIC-Bldg 6F, Minami-azabu 2-8-21, Minato-ku, Tokyo
TEL	03-6845-0166
Homepage URL
Email	kamohara-seika@umin.ac.jp

Sponsor
Institute	DHC Corporation
Institute
Department

Funding Source
Organization	Minamikyushu City Office
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	DHC Ethical Committee
Address	Azabudai 1-5-7, Minatoku, Tokyo, Japan
Tel	03-3585-2571
Email	kamohara@dhc.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	2019 Year 10 Month 15 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	Completed
Date of protocol fixation	2019 Year 07 Month 25 Day
Date of IRB	2019 Year 08 Month 09 Day
Anticipated trial start date	2019 Year 08 Month 10 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	2019 Year 10 Month 15 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043656