Tokyo, Jan. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060344) titled 'Study on the effects of sports drink consumption on psychological and physiological data' on Jan. 14.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Toyo University
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To analyze the effects of test food on psychological and physiological data
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single administration of test food1
Interventions/Control_2 - Single administration of test food2.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male
Key inclusion criteria - (1) Healthy males aged 18 years or older and under 30 years old at the time of obtaining consent.
(2) The ability to obtain consent.
(3) No health abnormalities at the time of obtaining consent.
Key exclusion criteria - (1)People deemed inappropriate for participation in this study by the principal investigator.
(2)People with irregular lifestyles, such as those working rotating night shifts.
(3)People who is sensitive to hot and humid environments or confined spaces.
(4)People weighing less than 50 kg.
(5)People with systolic blood pressure below 90 mmHg.
(6)People with allergies to the ingredients contained in the test food.
(7)People who have withdrawn their consent.
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 16 Day
Date of IRB - 2025 Year 12 Month 15 Day
Anticipated trial start date - 2026 Year 01 Month 14 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069033
Disclaimer: Curated by HT Syndication.
