UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051292 |
|---|---|
| Receipt number | R000058083 |
| Scientific Title | Verification of effects on autonomic nervous system, by inhalation of test food-inducing aroma |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2023/06/08 12:20:19 |
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Basic information
Public title
Verification of effects on autonomic nervous system, by inhalation of test food-inducing aroma
Acronym
Verification of effects on autonomic nervous system, by inhalation of test food-inducing aroma
Scientific Title
Verification of effects on autonomic nervous system, by inhalation of test food-inducing aroma
Scientific Title:Acronym
Verification of effects on autonomic nervous system, by inhalation of test food-inducing aroma
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify whether an inhalation of the test food-inducing aroma could reveal some kind of improvement effect on the autonomic nervous system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupil measurement
Key secondary outcomes
1. Subjective questionnaire
2. Skin temperature
3. Near-Infrared spectroscopy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Having a smell of the test food-inducing aromas to the volunteers for 2 min.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female volunteers ranging in age from 30 to 49.
(2) Volunteers having less than 30.0 kg/m2 of BMI.
(3) Volunteers who can give informed consent to partake in this trial 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, which might affect 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 having previous/present 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 with some kind of skin symptom, disease or disorder (e.g., atopic dermatitis).
(13) Pregnant, possibly pregnant, or lactating women.
(14) Volunteers who are now under another clinical test with some kind of medicine/food, or partook in that within a month before this trial.
(15) Others who have been determined as ineligible for participation, according to the investigator's opinions.
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 103-0021, 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 103-0021, 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
Graduate School of Comprehensive Human Sciences, Tsukuba University
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 | 06 | Month | 14 | 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
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058083
