UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059569 |
|---|---|
| Receipt number | R000067838 |
| Scientific Title | Effects of Acanthopanax senticosus Harms on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students - A Randomized, Double-blind, Parallel-group, Placebo-controlled Study - |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/28 14:20:09 |
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Basic information
Public title
Effects of food containing Acanthopanax senticosus Harms intake on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students(exam2).
Acronym
Effects of food containing Acanthopanax senticosus Harms intake on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students(exam2).
Scientific Title
Effects of Acanthopanax senticosus Harms on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students - A Randomized, Double-blind, Parallel-group, Placebo-controlled Study -
Scientific Title:Acronym
Effects of Acanthopanax senticosus Harms on anexiety, motivation to learn, quality of sleep, and fatigue associated with learning status in university students - A Randomized, Double-blind, Parallel-group, Placebo-controlled Study -
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether consumption of Acanthopanax senticosus food reduces psychological stress and enhances learning motivation and efficiency among students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurements taken after single intake of test food, followed by two measurements after replacing the test food (washout period: 1 month)
Subjective Items
1. Original questionnaire regarding overall health status and learning conditions
2. General Self-Efficacy Scale (GSES)
3. OSA questionnaire
4. STAI (State-Trait Anxiety Inventory)
Objective Items
1.Psychological Stress Analysis Using a Seat Sensor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved 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
Single-dose administration of Acanthopanax senticosus food
Interventions/Control_2
Single-dose administration of placebo food
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals
2. Individuals aged 18 or older who have received prior explanation of the study and whose informed consent can be obtained
3. Individuals who wish to participate in the study
Key exclusion criteria
1)Persons who have ingested foods containing Acanthopanax senticosus Harms within 3 months.
2)Persons who comsume health foods or supplements that may affect the study results.
3)Persons with allergies to Acanthopanax senticosus Harms.
4)Persons who are in hospital, on mdication, or undergoing treatment.
5)Persons with alcohol dependence.
6)Persons participating in other clinical studies.
7)Persons with a history of sever hepatic, renal, or cardiac disorders.
8)Persons with pre-existing or current hepatitis.
9)Persons with sever anemia.
10)Persons with hypertension (systolic blood pressure: 180 mmHg or higher, diastolic blood pressure: 90 mmHg or higher).
11)Persons deemed by the principal investigater and sub-investigater to be inappropriate to participate in the study.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Yoshiko |
Organization
Suzuka University of medicinal Science
Division name
Faculty of Health Science
Zip code
510-0293
Address
1001-1, Kishioka, Suzuka-city, Mie
TEL
059-383-8991
kyoshiko@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Mizoguchi |
Organization
Sun Chlorella Corp.
Division name
Production & Development Department
Zip code
600-8177
Address
369 Osaka-cho, Karasuma-dori Gojo-sagaru, Shimogyo-ku, Kyoto
TEL
075-288-3010
Homepage URL
mizoguchi@sunchlorella.co.jp
Sponsor or person
Institute
Suzuka University of medicinal Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of medicinal Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suzuka University of medicinal Science
Address
1001-1, Kishioka, Suzuka-city, Mie
Tel
+81-59-383-8991
kyoshiko@suzuka-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
鈴鹿医療科学大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 01 | 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 | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | 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
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067838
