UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051179 |
|---|---|
| Receipt number | R000058371 |
| Scientific Title | Psychological effects and changes in autonomic function indices induced by sudachi juice |
| Date of disclosure of the study information | 2023/05/28 |
| Last modified on | 2023/05/27 16:08:06 |
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Basic information
Public title
Psychological and autonomic effects of sudachi juice
Acronym
Psychological and autonomic effects of sudachi juice
Scientific Title
Psychological effects and changes in autonomic function indices induced by sudachi juice
Scientific Title:Acronym
Psychological effects and changes in autonomic function indices induced by sudachi juice
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We experience stress in our daily lives.
Taste is one of the ways to relieve stress.
Taste stimuli have been reported to affect the mental and autonomic nervous systems, and acidity has been shown to increase parasympathetic nervous system activity.
Although sudachi is popular in Tokushima Prefecture, the effect of the acidity of sudachi juice on the autonomic nervous system is not clear. Therefore, we decided to investigate the effects of sudachi juice on the emotional and autonomic nervous systems.
Basic objectives2
Others
Basic objectives -Others
To examine the psychological effects of drinking sudachi juice and changes in autonomic nervous system function in university students.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HF at 2 minutes after drinking each sample
Key secondary outcomes
Change in psychological stress response score (SRS-18) before and after intervention
Change in the following autonomic indices before and after the intervention
L/H (sympathetic nervous system activity index)
CVRR
Comparison of changes in HF between those from Tokushima Prefecture and those from other prefectures
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
sudachi juice
Interventions/Control_2
citric acid solution
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy University of Tokushima students
Key exclusion criteria
Persons with food allergies to citrus fruits
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Harutaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokushima University
Division name
Department of General Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima
TEL
088-633-9656
yharutaka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Okura |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
770-0042
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima
TEL
088-633-9656
Homepage URL
ookura.yoshi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board of Tokushima University
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima
Tel
088-633-7958
brinshoshienk@tokushima-u.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
| 2023 | Year | 05 | Month | 28 | 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 | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058371
