UMIN-CTR Clinical Trial

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
Email	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
Email	naohayashi@ila.titech.ac.jp

Sponsor
Institute	Tokyo Institute of Technology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049085