UMIN-CTR Clinical Trial

Basic information
Public title	A verification test of psychological and physiological effects of aroma or intake of coffee.
Acronym	A verification test of psychological and physiological effects of aroma or intake of coffee.
Scientific Title	A verification test of psychological and physiological effects of aroma or intake of coffee.
Scientific Title:Acronym	A verification test of psychological and physiological effects of aroma or intake of coffee.
Region	Japan

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

Objectives
Narrative objectives1	To verify psychological and physiological effect of coffee aroma, and psychological and physiological change by intake coffee.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Evaluation of autonomic nervous system, by iris measurement, skin temperature measurement and heart rate change * Evaluation of parasympathetic nervous system, by measurement for function of field of view and stabilometry *Flicker test
Key secondary outcomes	*POMS2 short version *VAS questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Resting more than 10min- measurements and questionnaires- suctioning coffee aroma- measurements and questionnaires- intake coffee- resting- measurements and questionnaires- resting- measurements and questionnaires
Interventions/Control_2	Resting more than 10min- measurements and questionnaires- suctioning water aroma- measurements and questionnaires- intake water- resting- measurements and questionnaires- resting- measurements and questionnaires
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Males and female who are students of NIHON UNIVERSITY aged more than 20 years when informed consent. 2. Subjects who are able to intake coffee. 3. Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	1.Subjects who don't good at coffee aroma 2. Subjects who have smoking habit. 3. Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer) 4. Subjects who are receiving medication due to treatment of disease. 5. In a past month, subjects who have had custom of taking or applying medicine for the treatment of diseases. (Except for cold but include for pollen allergy.) 6. Subjects who have stuffy nose such as allergic rhinitis, or subjects who are not able to determine aroma. 7. Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood. 8. Pregnant or expected pregnant, or lactating women. 9. Subjects who have symptom of dermatologic disease such as atopic dermatitis. 10. Subjects who feel pain in their knee, or subjects who feel pain or discomfort when bent their knee. 11. Subjects who have undergone surgery on investigation objective portion within the past 6 months. 12. Subjects who are participating the other clinical tests. Subjects who participated within a month prior to the current study and/or who plan to participate the other clinical tests. 13. Other who is determined ineligible by investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Motoko Middle name Last name Ohata
Organization	NIHON UNIVERSITY
Division name	College of Bioresource Science
Zip code	252-0880
Address	1866 Kameino, Fujisawa-shi, Kanagawa 252-0880 Japan
TEL	0466-84-3987
Email	Oohata.motoko@mihon-u.ac.jp

Public contact
Name of contact person	1st name Yukihiro Middle name Last name Yada
Organization	University of Tsukuba, School of Integrative
Division name	Global Majors
Zip code	305-8577
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL	029-853-7344
Homepage URL
Email	yada.yukihiro.gb@u.tsukuba.ac.jp

Sponsor
Institute	NIHON UNIVERSITY
Institute
Department

Funding Source
Organization	NIHON UNIVERSITY
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	University of Tsukuba, School of Integrative
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	2020 Year 08 Month 31 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	20
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	2019 Year 08 Month 16 Day
Date of IRB	2019 Year 08 Month 16 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2020 Year 01 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	2020 Year 01 Month 30 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=R000044846