UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect the change of taste and the odor to stress comdition during gum chewing
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoko Hasegawa
Organization	Hyogo College of Medicine
Division name	Department of Dentistry and Oral & Maxillofacial Surgery
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	Yoko Hasegawa
Organization	Hyogo College of Medicine
Division name	Department of Dentistry and Oral & Maxillofacial Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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