UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058213 |
|---|---|
| Receipt number | R000066513 |
| Scientific Title | A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial |
| Date of disclosure of the study information | 2025/06/18 |
| Last modified on | 2025/06/18 15:51:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial
Acronym
A study on the effects of the test product's flavor on relaxation
Scientific Title
A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial
Scientific Title:Acronym
A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relaxing effect of the test product in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain waves
Key secondary outcomes
Changes in Heart Rate Variability (HRV) parameters
Visual analogue scale
Likert scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants smell the aroma of the test product and then ingest the 150mL volume.
Interventions/Control_2
Participants smell the aroma of the control product and then ingest the 150mL volume.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 20 to 65.
2) Individuals of Japanese nationality.
3) Employees of Kobayashi Pharmaceutical Co., Ltd.
4) Individuals who have understood the purpose and procedures of this study and have voluntarily provided written informed consent to participate.
Key exclusion criteria
1) Individuals with an aversion to the flavor of test products.
2) Current smokers or those who have quit smoking for less than 6 months.
3) Individuals with a habit of excessive alcohol consumption (defined as a daily pure alcohol intake of 40g or more for men, and 20g or more for women).
4) Individuals currently using any medications, quasi-drugs, health foods, supplements, or Foods with Function Claims (e.g., GABA, L-theanine) purported to have stress-reducing or relaxing effects.
5) Individuals who plan significant changes to their lifestyle (e.g., diet, sleep, exercise habits), including long-term travel, during the study period.
6) Individuals taking any medication on a continuous basis for therapeutic purposes.
7) Individuals with nasal congestion (e.g., due to allergic rhinitis) or those unable to perceive or judge aromas.
8) Individuals with a history of or current serious disease of the heart, liver, kidneys, or digestive system.
9) Individuals with injuries on their forehead or left index finger.
10) Women who are pregnant, lactating, or planning to become pregnant.
11) Individuals currently participating in another clinical study or who have completed participation within one month prior to the start of this study.
12) Individuals with self-reported physical discomfort due to low atmospheric pressure.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Nishioka |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
m.nishioka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Tsujikami |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
Homepage URL
m.tsujikami@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
小林製薬株式会社 中央研究所(大阪府)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 18 | 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 | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066513
