UMIN-CTR Clinical Trial

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 Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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	2020 Year 10 Month 09 Day

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