UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057759
Receipt number R000066012
Scientific Title A Randomized Controlled Trial Evaluating the Effects of Basic Five-Taste Pairing Training and Umami Taste Recall Training
Date of disclosure of the study information 2025/05/02
Last modified on 2025/05/07 09:07:51

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Basic information

Public title

A Randomized Controlled Trial Evaluating the Effects of Basic Five-Taste Pairing Training and Umami Taste Recall Training

Acronym

A Randomized Controlled Trial Evaluating the Effects of Basic Five-Taste Pairing Training and Umami Taste Recall Training

Scientific Title

A Randomized Controlled Trial Evaluating the Effects of Basic Five-Taste Pairing Training and Umami Taste Recall Training

Scientific Title:Acronym

A Randomized Controlled Trial Evaluating the Effects of Basic Five-Taste Pairing Training and Umami Taste Recall Training

Region

Japan


Condition

Condition

Taste dysfunction

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. Comparison of the Effects of Umami Taste Recall Training and Basic Five-Taste Pairing Training
2. Investigation of the Taste Discrimination Mechanisms of Monosodium Glutamate (MSG), Inosine Monophosphate (IMP), and Guanosine Monophosphate (GMP)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Whether taste recognition thresholds for the five basic tastes improve through pairing training
2. Improvement in the ability to discriminate among three types of umami and salty taste

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

1 Basic Five Tastes
Three days of taste pairing training will be conducted.
2 Umami taste
Three days of taste recall training will be conducted using NaCl, monosodium glutamate, disodium inosinate, and disodium guanylate.

Interventions/Control_2

1. Basic Five Tastes
Taste recognition thresholds will be measured only on Day 1 and Day 4, without conducting the three-day pairing training.
2. Umami
Umami taste recognition thresholds will be measured only on Day 1 and Day 4, without conducting the umami taste recall training.

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.Healthy adult men and women aged 20 to 64
2.No history of taste disorders and not currently diagnosed with any taste abnormality by a physician
3.Individuals who have provided written informed consent to participate in the study

Key exclusion criteria

1.Individuals deemed unsuitable for participation in the study by a physician
2.Individuals who declined to participate in the study
3.Individuals with allergies to sucrose, sodium chloride, L(+)-tartaric acid, quinine hydrochloride, monosodium glutamate (MSG), disodium inosinate (IMP), or disodium guanylate (GMP)
4.Smokers

Target sample size

76


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Ebihara

Organization

Tohoku University Graduate School of medicine

Division name

Department of Rehabilitation Medicine

Zip code

9808574

Address

Seiryo-machi 1-1, Aoba-ku, Sendai

TEL

022-717-8574

Email

satoru.ebihara.c4@tohoku.ac.jp


Public contact

Name of contact person

1st name Midori
Middle name
Last name Miyagi

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

9808574

Address

Seiryo-machi 1-1, Aoba-ku sendai

TEL

022-717-7353

Homepage URL


Email

midori.miyagi.b5@tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

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

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

Tel

022-728-4105

Email

ec-med@grp.tohoku.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

2025 Year 05 Month 02 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

Preinitiation

Date of protocol fixation

2025 Year 05 Month 02 Day

Date of IRB


Anticipated trial start date

2025 Year 06 Month 15 Day

Last follow-up date

2030 Year 06 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 05 Month 02 Day

Last modified on

2025 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066012