UMIN-CTR Clinical Trial

Basic information
Public title	Influence of Umami (glutamate salts) on the taste of lower-salt solution.
Acronym	Influence of Umami (glutamate salts) on the taste of lower-salt solution.
Scientific Title	Influence of Umami (glutamate salts) on the taste of lower-salt solution.
Scientific Title:Acronym	Influence of Umami (glutamate salts) on the taste of lower-salt solution.
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to verify the influence of Umami on the taste of low salt solution.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Taste (salty taste, umami, palatability.)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	10
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	0.3 % NaCl aqueous solution (w / v)
Interventions/Control_2	0.3 % NaCl + 0.3 % glutamate Na aqueous solution (w / v)
Interventions/Control_3	0.3 % NaCl + 0.3 % glutamate K aqueous solution (w / v)
Interventions/Control_4	0.3 % NaCl + 0.3 % glutamate Ca aqueous solution (w / v)
Interventions/Control_5	0.3 % NaCl + 0.3 % glutamate Mg aqueous solution (w / v)
Interventions/Control_6	0.6 % NaCl aqueous solution (w / v)
Interventions/Control_7	0.6 % NaCl + 0.6 % glutamate Na aqueous solution (w / v)
Interventions/Control_8	0.6 % NaCl + 0.6 % glutamate K aqueous solution (w / v)
Interventions/Control_9	0.6 % NaCl + 0.6 % glutamate Ca aqueous solution (w / v)
Interventions/Control_10	0.6 % NaCl + 0.6 % glutamate Mg aqueous solution (w / v)

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult men and women who agreed to participate in this research with written informed consent.
Key exclusion criteria	1) Persons with eating disorders. (2) Persons with taste disorders. (3) Persons who has eaten within 2 hours. (4) Persons who judged that a principal investigator is inappropriate for participating in the examination.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hitomi Middle name Last name Hayabuchi
Organization	Fukuoka Women's University
Division name	Department of Food and Health Sciences, International College of Arts and Sciences
Zip code	813-8529
Address	1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
TEL	092-661-2411
Email	s-hayabuchi@fwu.ac.jp

Public contact
Name of contact person	1st name Kiyoshi Middle name Last name Koga
Organization	Fukuoka Women's University
Division name	General Affairs Management Group
Zip code	813-8529
Address	1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
TEL	092-661-2411
Homepage URL
Email	keiei@fwu.ac.jp

Sponsor
Institute	Fukuoka Women's University
Institute
Department

Funding Source
Organization	Fukuoka Women's University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ajinomoto co., Inc.
Name of secondary funder(s)	Ajinomoto co., Inc.

IRB Contact (For public release)
Organization	Research Ethics Review Committee at Fukuoka Women's University
Address	1-1-1 Kasumigaoka, Higashiku, Fukuoka, Japan
Tel	092-661-2411
Email	keiei@fwu.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	福岡女子大学(Fukuoka Women's University)

Other administrative information
Date of disclosure of the study information	2018 Year 12 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
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	2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date	2017 Year 10 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 17 Day
Last modified on	2019 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040181