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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017039
Receipt No. 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

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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
Email 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
Email cem17150@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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