UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044920 |
|---|---|
| Receipt number | R000051310 |
| Scientific Title | Verification of the effects of newly developed food and beverage products on oral function, swallowing function, and appetite |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2024/01/21 12:58:57 |
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Basic information
Public title
Verification of the effects of newly developed food and beverage products on oral function, swallowing function, and appetite
Acronym
Verification of newly developed food and beverage products
Scientific Title
Verification of the effects of newly developed food and beverage products on oral function, swallowing function, and appetite
Scientific Title:Acronym
Verification of newly developed food and beverage products
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of newly developed food and beverage products
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after comparison of eating and drinking prototypes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
No food or drink for 1 hour prior to tasting of the prototype.
Interventions/Control_2
As a before-and-after comparison, ready-made products and placebo (water).
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
Items for which the consent of the individual cannot be obtained
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | HOSHI |
| Middle name | |
| Last name | KAZUTO |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Sensory and Motor System Medicine
Zip code
1138655
Address
Hongo7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
0358008669
hoshi-ora@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | YONENAGA |
| Middle name | |
| Last name | KAZUMICHI |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Eat-loss Medicine
Zip code
1138655
Address
Hongo7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
0358008669
Homepage URL
yonenaga-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
ITO EN, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
ITO EN, LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, The University of Tokyo
Address
Hongo7-3-1, Bunkyo-ku, Tokyo, Japan
Tel
0358009891
eatingloss@gmail.com
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
| 2021 | Year | 07 | Month | 20 | 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
43
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051310
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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