UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020765 |
|---|---|
| Receipt number | R000023966 |
| Scientific Title | Influence of deliciousness on higher brain functions |
| Date of disclosure of the study information | 2016/01/28 |
| Last modified on | 2016/01/31 19:03:40 |
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Basic information
Public title
Influence of deliciousness on higher brain functions
Acronym
Influence of deliciousness on higher brain functions
Scientific Title
Influence of deliciousness on higher brain functions
Scientific Title:Acronym
Influence of deliciousness on higher brain functions
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Medicine in general | Neurology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present research used a mental arithmetic test to evaluate the influence on higher brain functions when chewing gum that included taste components perceived as "delicious", as compared to gum including taste components considered as "not delicious", thereby investigating whether changes in the deliciousness of food changes higher brain functions in a short period of time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mental arithmetic test
Key secondary outcomes
sensory test (visual analog scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Arithmetic test after delicious gum chewing
Interventions/Control_2
Arithmetic test after non-delicious gum chewing
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 jaws and teeth who could continuously chew gum
Key exclusion criteria
A person who has not obtained the informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Hasegawa |
Organization
Hyogo College of Medicine
Division name
Department of Dentistry and Oral & Maxillofacial Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
+81-798456677
cem17150@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Hasegawa |
Organization
Hyogo College of Medicine
Division name
Department of Dentistry and Oral & Maxillofacial Surgery
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
+81-798-45-6677
Homepage URL
cem17150@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
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 | 01 | Month | 28 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 14 | 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
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2016 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023966
