UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055253 |
|---|---|
| Receipt number | R000063137 |
| Scientific Title | A verification study of the improving effects of "kibou no meisui" on blood vessel, autonomic, and immune function: an open-label study |
| Date of disclosure of the study information | 2024/08/16 |
| Last modified on | 2025/02/17 11:18:52 |
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Basic information
Public title
A verification study of the improving effects of "kibou no meisui" on blood vessel, autonomic, and immune function: an open-label study
Acronym
A verification study of the improving effects of "kibou no meisui" on blood vessel, autonomic, and immune function: an open-label study
Scientific Title
A verification study of the improving effects of "kibou no meisui" on blood vessel, autonomic, and immune function: an open-label study
Scientific Title:Acronym
A verification study of the improving effects of "kibou no meisui" on blood vessel, autonomic, and immune function
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of "kibou no meisui" on blood vessel, autonomic, and immune function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Blood test, vascular age, and vascular aging
Key secondary outcomes
1. Questionnaires and medical record
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Kibou no meisui
Administration: Take daily whichever amount is greater, your body weight (mL) or your age (mL). Dilute five times with water when drinking.
*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Individuals aged between 50 and 80
4. Healthy individuals
5. Individuals who have never drunk "kibou no meisui"
6. Individuals who have received vaccination for COVID-19 at least three times
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, stroke disorder, dyslipidemia, hypertension, neoplastic disease, hemorrhagic disease, infectious disease, amyotrophy, heart disease, disc herniation, ossification of the posterior longitudinal ligament, spondylosis deformans, spinal stenosis, osteoporosis, atlantoaxial subluxation, unstable spine, scoliosis, spina bifida, spondylolisthesis, or any other chronic diseases
4. Individuals who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional foods/beverages on a daily basis
5. Individuals who are currently taking medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and foods related to the test food
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who suffer from COVID-19
9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
10. Individuals who are smokers
11. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Uto |
Organization
national university corporation Tokushima University
Division name
Graduate School of Technology, Industrial and Social Science, Tokushima University
Zip code
770-8506
Address
2-1, Minamijosanjima-cho, Tokushima city, Tokushima, Japan
TEL
088-656-7514
uto.yoshihiro@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Morihiro |
| Middle name | |
| Last name | Kumagai |
Organization
JES Co., Ltd.
Division name
Executive Vice President
Zip code
164-0003
Address
7F MSR Bldg., 3-8-13, Higashinakano, Nakano-ku, Tokyo, Japan
TEL
03-3364-7407
Homepage URL
kuma@j-smc.co.jp
Sponsor or person
Institute
national university corporation Tokushima University
Institute
Department
Personal name
Funding Source
Organization
national university corporation Tokushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Grace Medical Clinic
Name of secondary funder(s)
JES Co., Ltd.
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
グレースメディカルクリニック (熊本県)
Grace Medical Clinic (Kumamoto, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 16 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063137
