UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054182 |
|---|---|
| Receipt number | R000061869 |
| Scientific Title | Does the consumption of Fluid thickener suppress blood glucose elevation? |
| Date of disclosure of the study information | 2025/04/18 |
| Last modified on | 2024/04/17 19:31:19 |
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Basic information
Public title
Does the consumption of Fluid thickener suppress blood glucose elevation?
Acronym
Does the consumption of Fluid thickener suppress blood glucose elevation?
Scientific Title
Does the consumption of Fluid thickener suppress blood glucose elevation?
Scientific Title:Acronym
Does the consumption of Fluid thickener suppress blood glucose elevation?
Region
| Japan |
Condition
Condition
glucose intolerance
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect basic data for the development of new fluid thickener by evaluating their clinical efficacy in glucose tolerance tests on human subjects. Through this research, we aim to determine the additional benefits of thickening-adjusted foods to play an adjunctive role in the treatment of diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic information
Gender, date of birth, current medical history, complications, medical history, previous treatment, medications, educational history, exercise habits, drinking habits, smoking habits
Blood glucose
Blood glucose concentration over time Blood glucose concentration
Fullness and hunger are evaluated by 100-mm Visual Analogue Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention with thickened water before glucose tolerance test followed by intervention without thickened water before glucose tolerance test
Interventions/Control_2
Intervention with thickened water before glucose tolerance test after intervention without thickened water before glucose tolerance test
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal subjects in their 20s~40s with no abnormalities in blood tests
Key exclusion criteria
-Persons with type I or type II diabetes mellitus
-Persons with metabolic diseases
-Persons with infectious diseases
-Persons with psychiatric disease
-Persons with dietary restrictions
-Persons who are not eligible for the intervention in this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental university
Division name
Division of dysphagia Rehabilitation
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5750
harukatohara@hotmail.com
Public contact
Name of contact person
| 1st name | yuki |
| Middle name | |
| Last name | nagasawa |
Organization
Tokyo Medical and Dental university
Division name
Division of dysphagia Rehabilitation
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5559
Homepage URL
y.nagasawa.swal@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental university
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5560
y.nagasawa.swal@tmd.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 | 04 | Month | 18 | 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 | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | 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 | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061869
