UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043524 |
|---|---|
| Receipt number | R000049701 |
| Scientific Title | Brain health effect test by scent |
| Date of disclosure of the study information | 2021/03/04 |
| Last modified on | 2025/09/06 09:45:22 |
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Basic information
Public title
Brain health effect test by scent
Acronym
Brain health effect test by scent
Scientific Title
Brain health effect test by scent
Scientific Title:Acronym
Brain health effect test by scent
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Allocate 100 healthy adults to two groups, the group that randomly ingests the task and the group that does not do the test, and compare the brain activity after each task.
Basic objectives2
Others
Basic objectives -Others
Structural changes in the brain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Structure MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
5 days per week and 15min per day, fragrance identification task
Interventions/Control_2
No Task
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All subjects voluntarily signed the informed consent after detailed description and understanding of this study
Key exclusion criteria
Any other reasons unfavorable to participation in this MRI study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Koike |
Organization
Tokyo Institute of Technology
Division name
Institute of Innovative Research
Zip code
226-8503
Address
4259, Nagatsuta-cho midoriku yokohama kanagawa
TEL
045-924-5054
koike@cns.pi.titech.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Koike |
Organization
Tokyo Institute of Technology
Division name
Institute of Innovative Research
Zip code
226-8503
Address
4259, Nagatsuta-cho midoriku yokohama kanagawa
TEL
045-924-5054
Homepage URL
koike@cns.pi.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
BHQ
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
Tokyo Institute of Technology
Address
2-12-1, Oookayama, Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.ac.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
| 2021 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.rpd.titech.ac.jp/rpdiv/somu/hsr/v4/hsr05.html
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2075-1729/13/3/667
Number of participants that the trial has enrolled
29
Results
The results showed a significant correlation between GM changes and the sense of accomplishment and interest in training within the olfactory training group. Additionally, the group that learned about neuroplasticity and brain health showed a significantly smaller two-month GM decline than the control group.
Scores on the Curiosity and Exploration Inventory-II (CEI-II) were significantly correlated with GM changes only in the two intervention groups (the olfactory training group and the learning group).
Results date posted
| 2025 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study recruited a total of 90 participants, with recruitment continuing until the target number was reached for each age and sex group:
30s: 9 men and 9 women
40s: 12 men and 12 women
50s: 12 men and 12 women
60-64: 12 men and 12 women
Participants were included in the study if they met the following criteria:
No issues with MRI scans, such as having body metal, tattoos, or being pregnant.
No underlying diseases, psychiatric disorders, brain diseases, or lifestyle-related diseases.
Not a heavy smoker (25 or more cigarettes per day) or heavy drinker (20g or more of alcohol per day).
Participants were excluded from the study if their score on the Centre for Epidemiologic Studies Depression scale exceeded 16, indicating a tendency toward depression.
Participant flow
A total of 90 participants were recruited for this study.
Eligibility Assessment: All 90 participants were assessed for eligibility based on criteria including MRI compatibility, health status, lifestyle habits (smoking and drinking), and depression tendencies. No participants were excluded at this stage.
Group Assignment: All 90 eligible participants were stratified by sex and age and then randomly assigned to one of the three groups:
Control Group: 30 participants
Olfactory Training Group: 30 participants
Learning of Neuroplasticity and Brain Healthcare Group: 30 participants
Final Analysis: No dropouts were reported during the study period, and data from all 90 participants were included in the final analysis.
Adverse events
No adverse events were observed in this study.
Outcome measures
1. Primary Outcome Measure
Gray matter (GM) changes: This was the primary indicator used to measure the core objective of this study.
2. Secondary Outcome Measures
Psychological characteristics: Curiosity, personal growth initiatives, sense of accomplishment, and interest.
Behavioral indicator: Performance improvement on the odor classification task in the olfactory training group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049701
