UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039318 |
|---|---|
| Receipt number | R000044846 |
| Scientific Title | A verification test of psychological and physiological effects of aroma or intake of coffee. |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2020/10/09 12:05:10 |
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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
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
yada.yukihiro.gb@u.tsukuba.ac.jp
Sponsor or person
Institute
NIHON UNIVERSITY
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044846
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