UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050054 |
|---|---|
| Receipt number | R000057026 |
| Scientific Title | Evaluation of taste sensitivity and health effects of umami in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2024/01/29 14:59:26 |
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Basic information
Public title
Evaluation of taste sensitivity and health effects of umami in patients with type 2 diabetes mellitus
Acronym
Evaluation of taste sensitivity and health effects of umami in patients with type 2 diabetes mellitus
Scientific Title
Evaluation of taste sensitivity and health effects of umami in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Evaluation of taste sensitivity and health effects of umami in patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify lifestyle factors and biomarkers associated with decreased taste sensitivity in patients with type 2 diabetes and to examine the healthy effect of umami.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in detection thresholds for sweet.
Key secondary outcomes
Changes in detection thresholds for umami and salty, biometrics, lifestyle factors, and HR-QoL.
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will consume "dashi" before breakfast and dinner for the first month, then for the next month drinking hot water before breakfast and dinner with a normal diet.
Interventions/Control_2
Participants will consume hot water before breakfast and dinner with a normal diet for the first month, then for the next month consume "dashi" before breakfast and dinner.
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
1)Age >= 20
2)Type 2 diabetes patients attending our hospital
3)Those who agree to participate in the program
Key exclusion criteria
1) Those with diseases or taking medication that may cause taste abnormalities
2) Those who require special diet therapy such as iodine restriction or protein restriction
3) Those who are pregnant or breastfeeding
4) Those who the researchers judged difficult to participate the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Megu |
| Middle name | |
| Last name | Baden |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine/ Department of Lifestyle Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Japan
TEL
06-6879-3732
mbaden@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Niki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Japan
TEL
06-6879-3732
Homepage URL
akikoniki@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, 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
Ethic Review Board Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Japan
Tel
06-6210-8290
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
大阪大学大学院医学系研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057026
| 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 |
