UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059992 |
|---|---|
| Receipt number | R000068601 |
| Scientific Title | Investigation of the relaxing effects of functional aromatic components |
| Date of disclosure of the study information | 2025/12/06 |
| Last modified on | 2025/12/05 14:37:29 |
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Basic information
Public title
Investigation of the relaxing effects of functional aromatic components
Acronym
Relaxing effects of aroma
Scientific Title
Investigation of the relaxing effects of functional aromatic components
Scientific Title:Acronym
Investigation of the relaxing effects of functional aromatic components
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the relaxing effects of aroma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous function, salivary stress markers, and subjective evaluation of relaxation and mood
Key secondary outcomes
Changes in performance on the fatigue-loading task and subjective fatigue assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Ingestion of the test beverage
Interventions/Control_2
Ingestion of the control beverage
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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy women aged 20 to 59.
2. Individuals who understand the contents of the informed consent explanation and can provide written consent voluntarily.
3. Individuals who do not meet the exclusion criteria.
Key exclusion criteria
1. Individuals with a history of serious diseases of the brain, nervous system, cardiovascular system, renal failure or other severe disorders.
2. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders.
3.Individuals who are currently under treatment or those taking prescribed medications.
4. Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments.
5. Individuals who have olfactory or gustatory dysfunction.
6. Individuals who are currently pregnant or breastfeeding.
7. Individuals who have Citrus allergy.
8. Individuals who consumed citrus fruits, their juices, or foods containing citric acid at least three times per week within the month prior to giving consent.
9. Individuals who consumed citrus fruits, their juices, or foods containing citric acid between 8:00 p.m. on the day before the test and the start of the test.
10. Individuals who are currently participating in another clinical trial, or who have participated in another clinical trial within one months prior to obtaining consent.
11. Individuals who cannot follow the instructions for infection prevention.
12. Individuals judged as inappropriate for participation by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Integrated Health Science Co., Ltd.
Division name
Research Division
Zip code
5300011
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
TEL
080-2466-6100
contact@integhs.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Watanabe |
Organization
Integrated Health Science Co., Ltd.
Division name
Research Division
Zip code
5300011
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
TEL
080-2466-6100
Homepage URL
contact@integhs.jp
Sponsor or person
Institute
Integrated Health Science Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
POKKA SAPPORO Food & Beverage 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
The Ethics Committee of Umekita Digital Health
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
Tel
080-2466-6100
hrerc@integhs.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
| 2025 | Year | 12 | Month | 06 | 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
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068601
