UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062740 |
|---|---|
| Receipt number | R000071792 |
| Scientific Title | Mental fatigue stress test following ingestion of inositol-containing tablets |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/28 17:00:18 |
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Basic information
Public title
Mental fatigue stress test following ingestion of inositol-containing tablets
Acronym
Mental fatigue stress test following ingestion of inositol-containing tablets
Scientific Title
Mental fatigue stress test following ingestion of inositol-containing tablets
Scientific Title:Acronym
Mental fatigue stress test following ingestion of inositol-containing tablets
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate differences in feelings of fatigue among healthy subjects when performing a task after taking inositol or a placebo tablet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS Questionnaire (Mental Fatigue)
Key secondary outcomes
Saliva Test (Chromogranin A, Cortisol), Cognitrax
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Take one tablet containing 500 mg of inositol derived from rice bran
Interventions/Control_2
Take one tablet containing starch hydrolysate
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals in their 20s through 40s.
2. Healthy individuals with no chronic physical illnesses, as confirmed through a medical interview.
3. Individuals who have not consumed any food products with fatigue-recovery effects.
4. Individuals who have received a thorough explanation of the purpose and content of this trial, possess the capacity to give informed consent, have volunteered to participate after fully understanding the details, and are able to provide written consent to participate in this trial.
5. Individuals who are able to come to the facility on the designated test date and undergo the examination.
6. Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
1. Individuals currently suffering from any medical condition and undergoing drug treatment.
2. Individuals with severe symptoms caused by a medical condition, such as motor or respiratory disorders.
3. Individuals who are unable to refrain from taking over-the-counter supplements containing inositol during the study period.
4. Individuals with allergies (to medications or products related to the study materials).
5. Individuals who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
6. Individuals who are currently taking, or have taken within the past month, medications advertised to alleviate mental fatigue.
7. Individuals taking potent medications (as determined by the principal investigator).
8. Any other individuals whom the principal investigator deems unsuitable for participation in this trial.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Nakamura |
Organization
Tsuno Rice Fine Chemicals Co., Ltd
Division name
Planning and Development Dept 3. Research and Development Div.
Zip code
649-7194
Address
2283 CHONOMACHI KATSURAGI-CHO ITO-GUN WAKAYAMA 649-7194 JAPAN
TEL
0736-26-5032
nakamura.toshio@tsuno.co.jp
Public contact
Name of contact person
| 1st name | Amana |
| Middle name | |
| Last name | Ando |
Organization
Tsuno Rice Fine Chemicals Co., Ltd.
Division name
Section 2. Planning and Development Dept 3. Research and Development Div.
Zip code
649-7194
Address
2283 CHONOMACHI KATSURAGI-CHO ITO-GUN WAKAYAMA 649-7194 JAPAN
TEL
0736-26-5032
Homepage URL
ando.amana@tsuno.co.jp
Sponsor or person
Institute
Tsuno Rice Fine Chemicals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Tsuno Rice Fine Chemicals 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
Tsuno Food Industrial Ethics Committee
Address
94 SHINDEN KATSURAGI-CHO ITO-GUN WAKAYAMA 649-7194 JAPAN
Tel
0736-22-0061
rd_3dept@tsuno.co.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
築野ライスファインケミカルズ株式会社 TIWセンター (和歌山県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 31 | 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
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 11 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071792
