UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of psychological and physiological effects by suction of smell of the carbonated soft drink
Acronym	Investigation of psychological and physiological effects by suction of smell of the carbonated soft drink
Scientific Title	Investigation of psychological and physiological effects by suction of smell of the carbonated soft drink
Scientific Title:Acronym	Investigation of psychological and physiological effects by suction of smell of the carbonated soft drink
Region	Japan

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

Objectives
Narrative objectives1	Scientific verification of effects of smell of the carbonated soft drink to mind and body.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Evaluation of autonomic nervous system 2.Evaluation of parasympathetic nervous system
Key secondary outcomes	1. A self-report instrument to measure multiple mood states 2.Visual analog scale questionnaire of feeling

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	At rest testing.-Suction of control food for 2 min, then testing.-2 min rest.-Suction of test food for 2 min, then testing.
Interventions/Control_2
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	30 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	1. Females aged 30 to 45 years old who live near Tokyo. 2. Subjects who don't come with their child or children on the day of clinical test. 3. Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study. 4. Subjects who aren't bad at carbonated soft drinks. 5. Subjects who don't request disclosing of individual test results.
Key exclusion criteria	1. Subjects who have smoking habit. 2. Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer) 3. Subjects who are currently receiving medication due to treatment of disease. 4. In a past month, subjects who have had custom of taking or applying medicine for the treatment of diseases. 5. Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood. 6. Subjects who drink alcohol a lot. 7. Subjects who are aware their menopause symptom. 8. Pregnant or expected pregnant, or lactating women. 9. Subjects who have symptom of dermatologic disease such as atopic dermatitis. 10. Subjects who have undergone surgery on investigation objective portion within the past 6 months. 11. 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. 12. Subjects who themselves and/or their family are working for a company that develops and/or manufactures beverage. 13. Other who is determined ineligible by investigator.
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Kai
Organization	ASAHI SOFT DRINKS CO.,LTD.
Division name	Products Research & Development Laboratory, Research & Development Headquarters
Zip code	302-0106
Address	1-21, MIDORI 1-CHOME, MORIYA-SHI, IBARAKI
TEL	0297-46-1531
Email	toshiyuki.kai.a@asahiinryo.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
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	ASAHI SOFT DRINKS 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 Chushin Building, 3-3-5 Uchikanda 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	2017 Year 08 Month 09 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	2017 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 21 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	2017 Year 08 Month 09 Day
Last modified on	2020 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032745