UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053673 |
|---|---|
| Receipt number | R000061252 |
| Scientific Title | Trial to Verify the Effects of the Primary Aroma of Test Food on the Autonomic Nervous System |
| Date of disclosure of the study information | 2024/02/21 |
| Last modified on | 2024/02/21 15:13:17 |
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Basic information
Public title
Trial to Verify the Effects of the Primary Aroma of Test Food on the Autonomic Nervous System
Acronym
Trial to Verify the Effects of the Primary Aroma of Test Food on the Autonomic Nervous System
Scientific Title
Trial to Verify the Effects of the Primary Aroma of Test Food on the Autonomic Nervous System
Scientific Title:Acronym
Trial to Verify the Effects of the Primary Aroma of Test Food on the Autonomic Nervous System
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to investigate the effects of the test food aroma on the body, and to elucidate its physiological and psychological functions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pupillary light reflex
Key secondary outcomes
Subjective questionnaire (VAS questionnaire and Multifaceted emotional state scale), Skin temperature, Brain activity
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Smelling the aroma of the placebo food and test food 1.
Interventions/Control_2
Smelling the aroma of the placebo food and test food 2.
Interventions/Control_3
Smelling the aroma of the placebo food and test food 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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 30 to below 50 years at the time of consent acquisition.
2. Volunteers whose body mass index (BMI) is under 30kg/m2
3. Volunteers who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Volunteers being poor at having a smell of any kind of tea.
2. Volunteers falling into the habit of smoking (not less than half a year).
3. Volunteers who have periodically used health-specific / functional (e.g., gamma-aminobutyric acid, L-theanine)/ health foods including supplements, the trial results.
4. Volunteers with incompatible eyeballs/eyelashes for pupillometry.
5. Volunteers with any hindrances to a pupil measurement (e.g., dry eye).
6. Volunteers having a subjective symptom of claustrophobia and nyctophobia.
7. Volunteers being under some kind of continuous medical treatment.
8. Volunteers with the condition of being over-sensitiveness to cold, even during the summer season.
9. Volunteers with nasal congestion and/or wrong judgement of fragrance.
10. Volunteers with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
11. Volunteers with an external injury on their forehead or finger.
12. Volunteers who are participating in the other clinical trials and/or who have participated in the other clinical trials within a month prior to the current trial and/or who are planning to participate in the other clinical trials.
13. Volunteers with some kind of skin symptom, disease or disorder (e.g., atopic dermatitis).
14. Pregnant, possibly pregnant, or lactating women.
15. Volunteers deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
ITOEN, 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 Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2024 | Year | 02 | Month | 21 | 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
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061252
| Research Plan | |
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| Registered date | File name |
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