UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038301 |
|---|---|
| Receipt number | 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 | 2021/04/16 09:38:46 |
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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
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
kamohara-seika@umin.ac.jp
Sponsor or person
Institute
DHC Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043656
