Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056916) titled 'Hydration effect of the test beverages using the Beverage Hydration Index' 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 hydration effect of the test beverages using the Beverage Hydration Index
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 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 have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator.
2)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 15 Day
Last follow-up date - 2025 Year 03 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065007
Disclaimer: Curated by HT Syndication.
