UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050651 |
|---|---|
| Receipt number | R000057710 |
| Scientific Title | Sensory evaluation test of prototype of sake brewed by microorganisms isolated from marine. |
| Date of disclosure of the study information | 2023/03/24 |
| Last modified on | 2024/01/15 14:01:37 |
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Basic information
Public title
Sensory evaluation test of prototype of sake.
Acronym
Sensory evaluation test of prototype of sake.
Scientific Title
Sensory evaluation test of prototype of sake brewed by microorganisms isolated from marine.
Scientific Title:Acronym
Sensory evaluation test of prototype of sake brewed by microorganisms isolated from marine.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determination of optimal manufacturing conditions for sake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive evaluation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Intake and evaluation of sake No.1 with a different manufacturing method from sake used in other interventions.
Interventions/Control_2
Intake and evaluation of sake No.2 with a different manufacturing method from sake used in other interventions.
Interventions/Control_3
Intake and evaluation of sake No.3 with a different manufacturing method from sake used in other interventions.
Interventions/Control_4
Intake and evaluation of sake No.4 with a different manufacturing method from sake used in other interventions.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person familiar with sake tasting.
Key exclusion criteria
1) A person who is probably pregnant or is during pregnancy
2) A person who is during the lactation
3) A person who have diabetes or serious diseases of such as digestive organs, liver, pancreas, heart and kidney.
4) A person who have past history of above diseases.
5) A person who is prohibited from drinking alcohol.
6) A person who is not healthy on the test day.
7) A person who is suspected of being infected with the COVID-19.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Katsuyama |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Department of Biotechnology, Numazu Industrial Technical Support Center
Zip code
410-0022
Address
3981-1 Ohoka, Numazu-city, Shizuoka, 410-0022, Japan
TEL
+81-55-925-1101
satoshi1_katsuyama@pref.shizuoka.lg.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Katsuyama |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Department of Biotechnology, Numazu Industrial Technical Support Center
Zip code
410-0022
Address
3981-1 Ohoka, Numazu-city, Shizuoka, 410-0022, Japan
TEL
+81-55-925-1101
Homepage URL
satoshi1_katsuyama@pref.shizuoka.lg.jp
Sponsor or person
Institute
Shizuoka prefecture
Institute
Department
Personal name
Funding Source
Organization
Shizuoka prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee of Industrial Research Institute of Shizuoka Prefecture
Address
2078 Makigaya, Aoi-ward, Shizuoka-city, Shizuoka, 421-1298, Japan
Tel
+81-54-278-3028
sk-kikaku@pref.shizuoka.lg.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
| 2023 | Year | 03 | Month | 24 | 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
11
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
| 2020 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057710
