UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061407 |
|---|---|
| Receipt number | R000070261 |
| Scientific Title | Effects of a Single Intake of Dashi on Subjective Calmness and Psychological Stress |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/28 17:48:47 |
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Basic information
Public title
Study on Mood and Psychological Stress After a Single Intake of Dashi
Acronym
Dashi Mood and stress Study
Scientific Title
Effects of a Single Intake of Dashi on Subjective Calmness and Psychological Stress
Scientific Title:Acronym
DASHI-STRESS Study
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a single intake of dashi on psychological stress indicators and subjective calmness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary alpha-amylase measured at multiple time points before and after dashi intake
Key secondary outcomes
Heart rate variability (HRV), peripheral blood flow, blood pressure and pulse rate, and subjective measures using a visual analog scale (VAS) for calmness, anxiety, sleepiness, and fatigue.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
After completion of a mild mental stress task, participants consume 100 mL of dashi at 60 degrees Celsius as a single oral intake, and outcome measures are assessed repeatedly before and after intake. Each condition is conducted on separate days with a washout period of at least 7 days.
Interventions/Control_2
After completion of a mild mental stress task, participants consume 100 mL of a salt-control sample at 60 degrees Celsius as a single oral intake, with the sodium chloride concentration matched to that of the dashi condition. Outcome measures are assessed repeatedly before and after intake. Each condition is conducted on separate days with a washout period of at least 7 days.
Interventions/Control_3
After completion of a mild mental stress task, participants consume 100 mL of an umami-control sample at 60 degrees Celsius as a single oral intake, with the monosodium glutamate concentration adjusted based on that of the dashi condition. Outcome measures are assessed repeatedly before and after intake. Each condition is conducted on separate days with a washout period of at least 7 days.
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Healthy adults (male and female) aged 18 to 45 years.
- Individuals who have received a full explanation of the study objectives and procedures and have provided written informed consent.
- Individuals in good physical condition on the day of measurement and able to complete the study procedures without difficulty.
- Individuals who are able to normally consume dashi ingredients (seafood, kelp, and mushrooms).
Key exclusion criteria
- Individuals with a history of or currently receiving treatment for cardiovascular, metabolic, neurological, or endocrine disorders.
- Individuals who regularly use medications that may affect autonomic nervous system function (e.g., antihypertensive agents, anxiolytics, hypnotics/sleeping medications).
- Current smokers or individuals with a habitual pattern of excessive alcohol consumption.
- Individuals with taste or olfactory disorders, or with food allergies to seafood, kelp, umami seasonings, or related ingredients.
- Individuals who are pregnant or breastfeeding.
- Individuals reporting significant physical discomfort or poor health condition on the day of the study.
- Individuals judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Naho |
| Middle name | |
| Last name | Serizawa |
Organization
Toyo University
Division name
Faculty of Health and Sports Science
Zip code
115-8650
Address
1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
+81-3-5924-2819
serizawa@toyo.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Serizawa |
Organization
Toyo University
Division name
Faculty of Health and Sports Science
Zip code
115-8650
Address
1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
+81-3-5924-2819
Homepage URL
serizawa@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Plameries 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
Toyo University Ethical Review Board for Medical and Biological Research Involving Human Subjects
Address
2100, Kujirai, Kawagoe city, Saitama, Japan
Tel
049-239-1440
mlkks@toyo.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
| 2026 | Year | 04 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070261
