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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038301
Receipt No. R000043656
Scientific Title Health promotion measures with a dietary supplement containing catechin and folic acid among Japanese adults: The CHIRAN TEA/Folic acid supplement project.
Date of disclosure of the study information 2019/10/15
Last modified on 2019/10/15

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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 Open public recruiting
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
2019 Year 10 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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