UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063527 |
|---|---|
| Receipt number | R000072690 |
| Scientific Title | An Efficacy Study of a Functional Vinegar-containing Beverage for Cognitive Fatigue |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/05 16:14:31 |
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Basic information
Public title
An Efficacy Study of a Functional Vinegar-containing Beverage for Cognitive Fatigue
Acronym
An Efficacy Study of a Functional Vinegar-containing Beverage for Cognitive Fatigue
Scientific Title
An Efficacy Study of a Functional Vinegar-containing Beverage for Cognitive Fatigue
Scientific Title:Acronym
An Efficacy Study of a Functional Vinegar-containing Beverage for Cognitive Fatigue
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a functional beverage on cognitive fatigue induced by cognitive workload.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Performance on the cognitive fatigue-inducing task
Key secondary outcomes
Subjective fatigue score
Autonomic nervous system power and balance
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the Test beverage
Interventions/Control_2
Ingestion of the Control beverage
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 20 to 59 years
2. Individuals who understand the informed consent information and are able to provide voluntary written consent
Key exclusion criteria
1.Individuals with a history of neurological or cardiovascular disease, renal failure, or any other serious illness
2. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders
3. Individuals currently receiving ongoing treatment or taking medication for any medical condition
4. Individuals who regularly use pharmaceutical products, quasi-drugs, or health foods marketed or intended to alleviate stress or fatigue
5.Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments
6. Individuals with olfactory or taste disorders
7. Individuals who are currently pregnant or breastfeeding
8. Individuals with food allergies
9.Individuals who dislike sour tastes or carbonated beverages
10. Individuals who regularly consumed foods containing functional ingredients at least three times per week during the month prior to providing informed consent
11. Individuals who consumed foods containing functional ingredients between 8:00 p.m. on the day before the study and the start of the study procedures
12. Individuals who are currently participating in another clinical trial or who participated in another clinical trial within one month prior to providing informed consent
13.Individuals judged as inappropriate for participation by the principal investigator
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Integrated Health Science Co., Ltd.
Division name
Research Division
Zip code
530-0011
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
TEL
080-2466-6100
contact@integhs.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Watanabe |
Organization
Integrated Health Science Co., Ltd.
Division name
Research Division
Zip code
530-0011
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
TEL
080-2466-6100
Homepage URL
contact@integhs.jp
Sponsor or person
Institute
Integrated Health Science Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings 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
The Ethics Committee of Umekita Digital Health
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
Tel
080-2466-6100
hrerc@integhs.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 | 11 | Month | 12 | 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 | 09 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072690
