UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057565 |
|---|---|
| Receipt number | R000065717 |
| Scientific Title | Measurement of neuropsychological effects of SOYLAX on healthy volunteers. |
| Date of disclosure of the study information | 2025/04/09 |
| Last modified on | 2025/04/09 16:34:31 |
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Basic information
Public title
Measurement of neuropsychological effects of SOYLAX on healthy volunteers.
Acronym
Measurement of neuropsychological effects of SOYLAX on healthy volunteers.
Scientific Title
Measurement of neuropsychological effects of SOYLAX on healthy volunteers.
Scientific Title:Acronym
Measurement of neuropsychological effects of SOYLAX on healthy volunteers.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The neuropsychological effects of SOYLAX ingestion in healthy subjects were measured by VAS and compared with the effects of GABA ingestion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in the mood scale before and after consumption of the test foods will be compared using the VAS.
Key secondary outcomes
[Efficacy]
Measuring the neuropsychological effects of the test food by comparing mood scales after ingestion of the test food and after ingestion of the control food.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Phase I: Taking experimental food for 3days (once a day)
Wash out phase: About 1 week or more
Phase II: Taking three times control food
Interventions/Control_2
Phase I: Taking three times control food
Wash out phase: About 1 week or more
Phase II: Taking experimental food for 3days (once a day)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy adult men and women (not suffering from any disease) between the ages of 18 and 65 at the time of obtaining consent.
2) Persons who have received a full explanation of the study, are able to understand its contents, and are able to give their consent.
Key exclusion criteria
1) Those who may develop abdominal pain due to materials containing soybeans
2) Those who regularly use materials containing soybeans (3 days or more per week) and those who have regularly used such materials within 3 months prior to the pre-test
3) Those who have been diagnosed with malignant tumors, those who are undergoing treatment for cranial nerves, heart disease, kidney disease, diabetes, thyroid dysfunction, or have a history of liver disease or other serious diseases. However, this excludes diseases such as hypertension treatment, which are judged by the project manager to have no impact on the evaluation of this study.
4) Those who drink large amounts of alcohol (daily equivalent of 60 g of alcohol or more: about 1500 mL of beer, 540 mL of wine, 3 g of sake, or 180 mL of whiskey double)
5) Those who are at risk of developing allergies related to the study foods.
6) Those who are judged to be unsuitable as subjects based on their answers to the lifestyle questionnaire
7) Participants who have participated in other clinical studies within one month prior to obtaining consent to participate in this study, or who are scheduled to participate in other clinical studies after obtaining consent to participate in this study.
8) Other subjects who are judged to be inappropriate by the investigator.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kashima |
Organization
UHA Mikakuto Co. LTD.
Division name
Global Healthcare Research Laboratory
Zip code
540-0015
Address
5-2 Ju-nikenncho, Chuo-ku, Osaka
TEL
06-6767-6050
kasimay@uha-mikakuto.co.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kashima |
Organization
UHA Mikakuto Co., LTD.
Division name
Global Heallthcare Research Laboratory
Zip code
540-0015
Address
5-2 Ju-nikenncho, Chuo-ku, Osaka
TEL
0667676050
Homepage URL
kasimay@uha-mikakuto.co.jp
Sponsor or person
Institute
UHA Mikakuto Co., LTD.
Institute
Department
Personal name
Yasuhiro Kashima
Funding Source
Organization
UHA Mikakuto Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board
Address
26-14-1 Miharadai, Nerima-ku, Tokyo
Tel
08073457947
info@okutoeru.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 09 | 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
28
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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 08 | 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 | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065717
