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
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
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
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
