Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061500) titled 'Exploratory study of anti-fatigue effects of tea ingestion during exercise under heat stress' on May 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the anti-fatigue effects of single dose of tea during exercise under heat stress.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion of the test beverage.
Interventions/Control_2 - Ingestion of the control beverage.
Eligibility:
Age-lower limit - 20
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 Size - 8
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070370
Disclaimer: Curated by HT Syndication.
