UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054046
Receipt number R000061705
Scientific Title Investigation of changes in taste receptor genes and oral microbiota induced by dashi addition
Date of disclosure of the study information 2024/04/10
Last modified on 2024/04/17 08:58:04

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Basic information

Public title

Investigation of changes in taste receptor genes and oral microbiota induced by dashi addition

Acronym

Investigation of changes in taste receptor genes and oral microbiota induced by dashi addition

Scientific Title

Investigation of changes in taste receptor genes and oral microbiota induced by dashi addition

Scientific Title:Acronym

Investigation of changes in taste receptor genes and oral microbiota induced by dashi addition

Region

Japan


Condition

Condition

Diabetics or healthy adults

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

We will quantify taste receptor genes and oral microbiota and find out whether they change due to the addition of dashi.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in the expression level of sweet/umami receptor gene TAS1R3 in taste cells before and after addition of dashi

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Add dashi for 1 month

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients attending Osaka University Medicine Hospital or Osaka University Dentistry Hospital

Key exclusion criteria

1) Those with thyroid disease undergoing treatment
2) Those with allergies to kelp, blue fish, shiitake mushrooms, wheat, soybeans, and scallops
3) Those who are pregnant or breastfeeding
4) Those undergoing chemotherapy
5) Others who are deemed unsuitable by the researcher.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Megu
Middle name
Last name Baden

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita City, Osaka Prefecture

TEL

0668793732

Email

mbaden@endmet.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Kento
Middle name
Last name Mitsushio

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita City, Osaka Prefecture

TEL

0668793732

Homepage URL


Email

mitsushio@endmet.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Medical Hospital Ethics Review Committee

Address

2-2 Yamadaoka, Suita City, Osaka Prefecture

Tel

0662108296

Email

rinri@hp-crc.med.osaka-u.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

2024 Year 04 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


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

2024 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2024 Year 06 Month 01 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 04 Month 03 Day

Last modified on

2024 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061705


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name