UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048419 |
|---|---|
| Receipt number | R000054897 |
| Scientific Title | A clinical study to evaluate the psychological effects of vinegar beverage |
| Date of disclosure of the study information | 2022/07/22 |
| Last modified on | 2022/11/25 11:43:56 |
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Basic information
Public title
A clinical study to evaluate the psychological effects of vinegar beverage
Acronym
A clinical study to evaluate the psychological effects of vinegar beverage
Scientific Title
A clinical study to evaluate the psychological effects of vinegar beverage
Scientific Title:Acronym
A clinical study to evaluate the psychological effects of vinegar beverage
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the psychological effects(refresh, relax) of drinking vinegar beverage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain wave (frequency component)
Heart rate (HF, LF)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Attach devices(simple type electroencephalograph, simple type electrocardiograph) -> Experimental task(Transcription of voice data for 20 minutes) -> Intake of test food(10 minutes) -> Experimental task(Transcription of voice data for 20 minutes) -> Remove devices
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects who meet all the conditions in a screening test
1) Healthy people whose age of 20 years or more and less than 65 years old
2) Subjects having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects having disability of the digestive system
2) Subjects who have the possibility of developing allergic symptoms by the test food
3) Subjects having an abnormality in the electrocardiogram
4) Subjects deemed unsuitable by the investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Jingu |
Organization
Kanazawa Institute of Technology
Division name
Department of Psychology,Faculty of Information Frontier
Zip code
924-0838
Address
3-1 Yatsukaho, Hakusan, Ishikawa
TEL
076-274-7296
jinguh@neptune.kanazawa-it.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Hagiwara |
Organization
Mizkan Co., Ltd.
Division name
Research and Development Department, Marketing Division
Zip code
475-8585
Address
2-6, Nakamura-cho, Handa, Aichi
TEL
0569-24-5107
Homepage URL
kenta_hagiwara@mizkan.co.jp
Sponsor or person
Institute
Kanazawa Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Mizkan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mizkan Co., Ltd.
Address
2-6, Nakamura-cho, Handa, Aichi
Tel
0569-21-3331
kenta_hagiwara@mizkan.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
| 2022 | Year | 07 | Month | 22 | 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
10
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
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054897
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
