UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025054 |
|---|---|
| Receipt number | R000028825 |
| Scientific Title | Verification of flavor and taste sensed by visually impaired |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2024/06/05 11:07:41 |
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Basic information
Public title
Verification of flavor and taste sensed by visually impaired
Acronym
Verification of flavor and taste sensed by visually impaired
Scientific Title
Verification of flavor and taste sensed by visually impaired
Scientific Title:Acronym
Verification of flavor and taste sensed by visually impaired
Region
| Japan |
Condition
Condition
Healthy volunteers
Visually impaired volunteers
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of taste caught by people with visual impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Video image evaluation, blood sampling and saliva analysis, skin electrical response, pupil diameter analysis.
Key secondary outcomes
Subjective evaluation - interview data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention in healthy subjects
Interventions/Control_2
Intervention in the visually impaired
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women
Key exclusion criteria
Person with olfactory and visually impaired, person with some disability in cognitive function, person with some disability in perception and exercise function, person with disabilities in the oral cavity or swallowing function, interfering with the conversation, people with a history of allergy (alcohol, food allergies),poor physical condition.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mieko Uchiyama |
Organization
Graduate School of Health Sciences, Niigata University
Division name
Nursing
Zip code
Address
2-746 Asahimachoi-dori, chiuo-ku, Niigata
TEL
025-227-2263
uchiyama@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mieko Uchiyama |
Organization
Graduate School of Health Sciences, Niigata University
Division name
Nursing
Zip code
Address
2-746 Asahimachoi-dori, chiuo-ku, Niigata
TEL
025-227-2263
Homepage URL
uchiyama@clg.niigata-u.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences, Niigata University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Address
Tel
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
| 2016 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028825
