Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056915) titled 'Effect of test beverage on plasma volume recovery from exercise-induced dehydration' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Otsuka Pharmaceutical Co., Ltd.
Condition:
Condition - Healthy adult males
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect of test beverage on plasma volume recovery from exercise-induced dehydration.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Beverage A -> washout period -> Beverage B -> washout period -> Water
Interventions/Control_2 - Beverage B -> washout period -> Water -> washout period -> Beverage A
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male
Key inclusion criteria - 1)Subjects who are voluntarily giving written informed consent.
2)Healthy adult males over 20 years of age.
3)Subjects who have an exercise habit (daily exercise; jogging, treadmill running, bicycle pedaling, etc.)
4)Subjects who can take meals, take blood and urine samples, and keep a resting state on the schedule indicated by investigators.
Key exclusion criteria - 1)Subjects who make a blood donation of 400mL within 12weeks before the start of the intake or that of 200mL within 4weeks before the start of the intake.
2)Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator.
3)Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target Size - 21
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 01 Month 30 Day
Date of IRB - 2025 Year 01 Month 30 Day
Anticipated trial start date - 2025 Year 02 Month 05 Day
Last follow-up date - 2025 Year 04 Month 27 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065004
Disclaimer: Curated by HT Syndication.
