UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038649 |
|---|---|
| Receipt number | R000044037 |
| Scientific Title | An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea. |
| Date of disclosure of the study information | 2020/11/23 |
| Last modified on | 2020/11/20 09:46:02 |
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Basic information
Public title
An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Acronym
An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Scientific Title
An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Scientific Title:Acronym
An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the influence to auto-nervous system and to sedative action by oral consumption of the food which contain the aroma component of black tea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Evaluation of autonomic nervous system (pupil versus light reflection, skin temperature)
* Evaluation of central nervous system (stabilometry, brain stress, NIRS)
Key secondary outcomes
*Multiple mood scale (short version, 40 question)
*VAS questionnaire about fragrance and mood
* Incidence of adverse events and side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Intake one tablet of test food - Measurement of autonomic nervous system - Intake one tablet of test food - Measurement of central nervous system 1 - Intake one tablet of test food - Measurement of central nervous system 2
Interventions/Control_2
Intake one tablet of control food - Measurement of autonomic nervous system - Intake one tablet of control food - Measurement of central nervous system 1 - Intake one tablet of control food - Measurement of central nervous system 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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Females aged 20 to 39 years old when consent obtain.
(2) Females 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) Females who dislike the fragrance of black tea
2) Females who have smoking habit.
3) Females who are cold-sensitive constitution.
4) Females who are receiving medication due to treatment of some disease within current one month before the test.
5) Females who are receiving treatment for pollen allergy within current one month before the test.
6) Females with stuffy nose such as allergic rhinitis or females who can't identify the fragrance.
7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
8) Females with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more.
9) Females who are pregnant or are lactating.
10) Females who have symptom of dermatologic disease such as atopic dermatitis.
11) Females who have undergone surgery on investigation objective portion within the past 6 months.
12) Females who feel pain or discomfort when they bend their knee.
13) Females who are participating the other clinical tests of medicines or foods. Females who participated other clinical tests of medicines or foods within a month prior to the current study.
14) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Suzuki |
Organization
Mitsui Norin Co., Ltd.
Division name
R&D Group
Zip code
426-0133
Address
223-1 Miyabara, Fujieda-city, Shizuoka-prefecture, 426-0133,JAPAN
TEL
054-648-2600
masayuks@mitsui-norin.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 Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Mitsui Norin 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 Sanwauchikanda 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 | 11 | Month | 23 | 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
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044037
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