Tokyo, April 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061299) titled 'Anti-Fatigue Effects of Tea Intake and Its Mechanisms' on April 17.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Integrated Health Science Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the anti-fatigue effects of tea intake over 4 weeks and its underlying mechanisms.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of the test tea.
Interventions/Control_2 - Intake of the control tea.
Eligibility:
Age-lower limit - 25
years-old
Gender - Female
Key inclusion criteria - 1. Healthy female individuals aged 25 to under 60 years.
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 who have smoked within one year prior to obtaining informed consent.
6. Individuals who are currently pregnant or breastfeeding.
7. Individuals with food allergies.
8. Individuals who consumed an average of five or more cups of tea 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 informed 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 - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 03 Day
Anticipated trial start date - 2026 Year 04 Month 17 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070139
Disclaimer: Curated by HT Syndication.
