UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061500 |
|---|---|
| Receipt number | R000070370 |
| Scientific Title | Exploratory study of anti-fatigue effects of tea ingestion during exercise under heat stress |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/08 20:28:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory study of anti-fatigue effects of tea ingestion during exercise under heat stress
Acronym
Exploratory study of anti-fatigue effects of tea ingestion during exercise under heat stress
Scientific Title
Exploratory study of anti-fatigue effects of tea ingestion during exercise under heat stress
Scientific Title:Acronym
Exploratory study of anti-fatigue effects of tea ingestion during exercise under heat stress
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-fatigue effects of single dose of tea during exercise under heat stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in autonomic nervous system activity and salivary stress markers after recovery from fatigue.
Key secondary outcomes
Subjective fatigue sensation after recovery from fatigue.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. Individuals who aged 20 to 39 and 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 do not meet any of the exclusion criteria.
Key exclusion criteria
1. Individuals with a history of serious diseases of the brain, nervous system, cardiovascular system, renal failure or other severe disorders.
2. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders.
3. Individuals who are currently under treatment or those taking prescribed medications.
4. Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments.
5. Individuals with food allergies.
6. Individuals who have smoked within one year prior to obtaining informed consent.
7. Individuals who consumed an average of five or more cups of tea per day within one month prior to obtaining informed consent.
8. Individuals who consumed an average of 5 or more lemons per day, or lemon-containing foods equivalent to about 5 lemons per day within one month prior to obtaining informed consent.
9. Individuals who are currently participating in another clinical trial, or who have participated in another clinical trial within one month prior to obtaining consent.
10. Individuals who cannot follow instructions for infection prevention (e.g., wearing a mask).
11. Individuals judged as inappropriate for participation by the principal investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka Metropolitan University
Division name
Research Center for Urban Health and Sports
Zip code
558-8585
Address
3-3-138 Sugimoto Sumiyoshi Osaka 558-8585 JAPAN
TEL
06-6605-2950
kokazaki@omu.ac.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
5300011
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
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association Wellness Laboratory
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Integrated Health Science Co., Ltd.
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 | 05 | 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
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 | 04 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 30 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070370
