UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025567 |
|---|---|
| Receipt number | R000029425 |
| Scientific Title | A randomized controlled trial about the effect that taste affect on cerebral blood flow at chewing on healthy dentulous individuals |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2020/07/12 01:09:42 |
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Basic information
Public title
A randomized controlled trial about the effect that taste affect on cerebral blood flow at chewing on healthy dentulous individuals
Acronym
A randomized controlled trial about taste and the cerebral blood flow
Scientific Title
A randomized controlled trial about the effect that taste affect on cerebral blood flow at chewing on healthy dentulous individuals
Scientific Title:Acronym
A randomized controlled trial about taste and the cerebral blood flow
Region
| Japan |
Condition
Condition
Healthy dentulous individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study for effect of cerebral blood flow in emotion
Basic objectives2
Others
Basic objectives -Others
Practical
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The increase and decrease of the oxygen hemoglobin concentration in the cerebral blood flow
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Pleasant Gum
Interventions/Control_2
Unpleasant Gum
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No brain cardiovascular disease
Healthy dentulous individuals
Obtain with the agreement of IC
Key exclusion criteria
Brain cardiovascular disease
Entulous individuals
Don't obtain the agreement of IC
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Kishimoto |
Organization
Hyogo College of medicine
Division name
Faculty of Oral and Maxillofacial Surgery
Zip code
663-8501
Address
1-1,Mukogawa-cyou,Nishinomiya,Hyogo Building No.2, 5nd floor
TEL
0798-45-6677
kishihiro@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Hasegawa |
Organization
Hyogo College of medicine
Division name
Faculty of Oral and Maxillofacial Surgery
Zip code
663-8501
Address
1-1,Mukogawa-cyou,Nishinomiya,Hyogo Building No.2, 5nd floor
TEL
0798-45-6677
Homepage URL
cem17150@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of medicine
Faculty of Oral and Maxillofacial Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of medicine Faculty of Oral and Maxillofacial Surgery
Address
1-1,Mukogawa-cyou,Nishinomiya,Hyogo
Tel
0798-45-6677
ay-sakuramoto@hyo-med.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
| 2017 | Year | 01 | 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
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
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029425
