UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059719 |
|---|---|
| Receipt number | R000068268 |
| Scientific Title | Effects of Test Beverage Consumption on Health Benefits |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/09 17:20:58 |
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Basic information
Public title
Effects of Test Beverage Consumption on Health Benefits
Acronym
Effects of Test Beverage Consumption on Health Benefits
Scientific Title
Effects of Test Beverage Consumption on Health Benefits
Scientific Title:Acronym
Effects of Test Beverage Consumption on Health Benefits
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the health-promoting effects of four-week test beverage consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of physiological, biochemical, and neuropsychological parameters before and after the test beverage consumption period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Test beverage consumption twice daily for four weeks
Interventions/Control_2
Placebo beverage consumption twice daily for four weeks
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 20 to 65 years who do not meet the exclusion criteria.
2. Individuals who understand the contents of the informed consent explanation and can provide written consent voluntarily.
3. Individuals who are not continuously consuming beverages containing the main ingredients of the test beverage.
Key exclusion criteria
1. Individuals with a history of serious diseases of the brain, nervous system, cardiovascular system, or other severe disorders, or those currently under treatment (including individuals taking prescribed medications).
2. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders.
3. Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments.
4. Individuals who are currently pregnant or breastfeeding.
5. Individuals who are currently participating in another clinical trial, or who have participated in another clinical trial within two months prior to obtaining consent.
6. Individuals judged as inappropriate for participation by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Joto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co., Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6, Nakamura-cho, Handa-shi, Aichi
TEL
0569-24-5139
yoshimoto_jyoutou@mizkan.co.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 530-0011, JAPAN
TEL
080-2466-6100
Homepage URL
kyosuke.watanabe@integhs.jp
Sponsor or person
Institute
Mizkan Holdings 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 Fatigue Science Laboratory Inc.
Address
7-4-21 Nishinakajima, Yodogawa-ku, Osaka 532-0011, Japan
Tel
06-6308-1190
info@fatigue.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
一般社団法人プレシジョンヘルスケア研究機構
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 11 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 25 | 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 | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068268
