UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049703
Receipt number R000056609
Scientific Title Investigation of the effect of adding umami ingredients and receptor gene polymorphism of salty and Umami
Date of disclosure of the study information 2022/12/06
Last modified on 2022/12/06 14:33:04

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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 or person

Institute

Fujita Health University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056609


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name