UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043027 |
|---|---|
| Receipt number | R000049085 |
| Scientific Title | Effect of salt taste training on salt taste threshold in Japanese healthy people |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2021/01/16 09:05:15 |
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Basic information
Public title
Effect of salt taste training on salt taste threshold
Acronym
Effect of salt taste training on salt taste threshold
Scientific Title
Effect of salt taste training on salt taste threshold in Japanese healthy people
Scientific Title:Acronym
Effect of salt taste training on salt taste threshold in Japanese healthy people
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of simple and easy taste training on salt threshold in Japanese healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salt threshold after 4-week salt taste training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Filter papers soaked in NaCl solutions of different concentrations and then dried were tasted daily.
Interventions/Control_2
control/no intervention
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy non-smoker
Key exclusion criteria
taste disorder or neurological disorder, smoking habits
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | Hayashi |
| Last name | HAYASHI |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
1528552
Address
Ookayama 2-12-1, Meguro, Tokyo Japan
TEL
0357343434
naohayashi@ila.titech.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | Hayashi |
| Last name | Hayashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
1528552
Address
Ookayama 2-12-1, Meguro, Tokyo Japan
TEL
0357343434
Homepage URL
naohayashi@ila.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Institute of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokyo Institute of Technology's Human Subjects Research Ethics Review Comittee
Address
Ookayama 2-12-1, Meguro, Tokyo, 1528552 Japan
Tel
0357343802
hitorinri@jim.titech.ac.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
| 2021 | Year | 02 | Month | 10 | 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
24
Results
ANOVA showed an interaction trend (p=0.06) between the number of measurements and the presence of training. A post-hoc Wilcoxon's signed rank sum test showed that the salt threshold of the training group decreased significantly than that before training.
Results date posted
| 2021 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049085
| Research Plan | |
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| Registered date | File name |
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