UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017039 |
|---|---|
| Receipt number | R000019754 |
| Scientific Title | Effect the change of taste and the odor to stress comdition during gum chewing |
| Date of disclosure of the study information | 2015/04/04 |
| Last modified on | 2016/06/28 20:13:32 |
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Basic information
Public title
Effect the change of taste and the odor to stress comdition during gum chewing
Acronym
Flavor-enhanced cortisol release during gum chewing
Scientific Title
Effect the change of taste and the odor to stress comdition during gum chewing
Scientific Title:Acronym
Flavor-enhanced cortisol release during gum chewing
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Medicine in general | Geriatrics | Oral surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study measured cortisol in saliva secreted at different gum chewing of the odor and tested it for the purpose of taste and odor determining different stress reaction during chewing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of secreted cortisol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
gum
Interventions/Control_2
delicious gum
Interventions/Control_3
unpalatable gum
Interventions/Control_4
gum base
Interventions/Control_5
Gum taste only or odor only
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
Healthy subjects
Key exclusion criteria
1. Those who have apparent cognitive impairment (MMSE < 20)
2. Those who are judged by a doctor as inappropriate candidates
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
0798-45-6677
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
0798-45-6677
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
| 2015 | Year | 04 | Month | 04 | 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
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | 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
| 2015 | Year | 04 | Month | 03 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019754
