UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effect of adding umami ingredients and receptor gene polymorphism of salty and Umami
Acronym	the effect of adding umami
Scientific Title	Investigation of the effect of adding umami ingredients and receptor gene polymorphism of salty and Umami
Scientific Title:Acronym	the effect of adding umami
Region	Japan

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

Objectives
Narrative objectives1	In this study, we will calculate the estimated umami intake, estimated protein intake, and salt intake from volunteers' umami/salt preferences and one-week dietary records. Furthermore, we will examine the relationships between umami taste/salt receptor gene polymorphisms, changes in intestinal flora, taste preferences, estimated umami taste, and protein intake. Select 20 people who like salt and have a high salt intake, and observe changes after administering umami preparations (MSG).
Basic objectives2	Others
Basic objectives -Others	Efficacy
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Differences in intestinal microbiota due to differences in taste preferences
Key secondary outcomes	Percent change in biometric parameters such as gut microbiota and blood pressure/salt intake compared to baseline, after 2 weeks of MSG administration Differences in taste preferences, blood pressure, and intestinal microbiota according to taste receptor gene polymorphisms

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	MSG administrating
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	1. People received sufficient explanation, and then obtained written inforned consent by with sufficient understanding. 2. People aged 20 or over and under 65 at the time of obtaining consent
Key exclusion criteria	1.People who have a taste disorder as complication 2. Underage 3. People who have severe sensory impairmen 4.People who have mental illness such as dementia 5.Unsuitable conditions found by a doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Shibata
Organization	Fujita Health University
Division name	Department of Gastroenterology and Hepatology
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL	+81562932324
Email	shibat03@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Shibata
Organization	Fujita Health University
Division name	Department of Gastroenterology and Hepatology
Zip code	470-1192
Address	1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL	+81562932324
Homepage URL
Email	shibat03@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Society for Research on Umami Taste
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University
Address	1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel	+81562932865
Email	f-irb@fujita-hu.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	2022 Year 12 Month 06 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	Open public recruiting
Date of protocol fixation	2022 Year 01 Month 15 Day
Date of IRB	2022 Year 04 Month 14 Day
Anticipated trial start date	2022 Year 05 Month 09 Day
Last follow-up date	2024 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 12 Month 06 Day
Last modified on	2022 Year 12 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056609