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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034314
Receipt No. R000039119
Scientific Title Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Date of disclosure of the study information 2018/09/28
Last modified on 2019/04/16

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Basic information
Public title Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Acronym Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Scientific Title Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Scientific Title:Acronym Evaluation of autonomic nervous system before and after inhalation of the fragrant component added to ethanol water.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of action to human mind and body by smelling ethyl caproate and isoamyl acetate, those are primary ginjo-aroma of sake, then discover and use new knowledge of sake fragrance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of autonomic nervous system
Key secondary outcomes Multifaceted emotional state scale shortened version
VAS questionnaire about change of feeling
VAS questionnaire about fragrance
VAS questionnaire about sake

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Smell the scent of 2 kinds of component (A,B) in order A and B.
Interventions/Control_2 Smell the scent of 2 kinds of component (A,B) in order B and A.
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
25 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria (1) Females aged 25 to 45 years old.
(2)Subjects who like sake, especially ginjo-sake and have experience of drinking sake.
(3) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria (1)Subjects who dislike the scent of sake.
(2)Subjects who can't drink alcohol or who can drink alcohol little.
(3) Subjects who have smoking habit.
(4) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
(5) During the past month, subjects who have been received medication for the treatment of diseases.
(6) During the past month, subjects who have been received treatment of pollen allergy.
(7) Subjects who have stuffy nose from allergic rhinitis or who can't distinguish scent.
(8) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
(9) Subjects with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more.
(10) Pregnant or expected pregnant, or lactating women.
(11) Subjects who have symptom of dermatologic disease such as atopic dermatitis.
(12) Subjects who have undergone surgery on investigation objective portion within the past 6 months.
(13) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study.
(14) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells alcoholic beverages, health / functional foods and cosmetics.
(15) Others who have been determined ineligible by investigator.
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suguru Fujiwara
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Numa
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Gekkeikan Sake Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 09 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 Completed
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 09 Month 20 Day
Anticipated trial start date
2018 Year 09 Month 29 Day
Last follow-up date
2018 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039119

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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