UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033569 |
|---|---|
| Receipt number | R000038282 |
| Scientific Title | Evaluation of the effect of the black tea-derived aroma on automatic nervous system and cerebral blood flow in healthy adults. |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2018/07/31 08:58:24 |
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Basic information
Public title
Evaluation of the effect of the black tea-derived aroma on automatic nervous system and cerebral blood flow in healthy adults.
Acronym
Evaluation of the effect of the black tea-derived aroma on automatic nervous system and cerebral blood flow in healthy adults.
Scientific Title
Evaluation of the effect of the black tea-derived aroma on automatic nervous system and cerebral blood flow in healthy adults.
Scientific Title:Acronym
Evaluation of the effect of the black tea-derived aroma on automatic nervous system and cerebral blood flow in healthy adults.
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the black tea-derived aroma on autonomic nervous system and cerebral blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupillary reaction to light
Cerebral blood flow
Key secondary outcomes
Cognitive tasks
Questionnaires
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
inhalation of black tea flavor
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged from 20 to 65 years, when giving the informed consent.
2) Individuals giving the written informed consent.
Key exclusion criteria
1) Individuals who declare the allergy symptoms against test diets.
2) Individuals who have anamnesis of cranial nerve disease.
3) Individuals who have anamnesis of the autonomic nervous system.
4) Individuals who have mental symptoms, or who have been diagnosed as mental disorder.
5) Individuals who are being treated with hormone, or who have been diagnosed as menopausal symptoms
6) Individuals who can't perform the study because it's olfactory impairment.
7) Individuals who regularly take drugs or health foods affecting cognitive functions
8) Individuals who regularly take drugs of health foods affecting autonomic nervous system.
9) Individuals who is not suitable for subjects by pre-test questionnaire.
10) Individuals who are planned to participate in other clinical study.
11) Individuals who are pregnant or breastfeeding during the study.
12) Individuals who sometimes have irregular lifestyles during the study.
13) Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Kobayashi |
Organization
Kirin Company, Limited
Division name
Research and Development Division, Research Laboratories for Health Science & Food Technologies
Zip code
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL
080-2016-9331
keiko_kobayashi@kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kobayashi |
Organization
Kirin Company, Limited
Division name
Research and Development Division, Research Laboratories for Health Science & Food Technologies
Zip code
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL
080-2016-9331
Homepage URL
keiko_kobayashi@kirin.co.jp
Sponsor or person
Institute
Kirin Company, Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2018 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038282
