Pilot study on the effect of test beverage on body fluid recovery from exercise-induced dehydration.

UMIN ID: UMIN000050548

Registered date:30/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult males
• Date of first enrollment: 2023/03/13
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Control beverage -> washout period -> Test beverage
Test beverage -> washout period -> Control beverage

Outcome(s)

• Primary Outcome: Percentage changes in plasma volume
• Secondary Outcome: Urine volume

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1)Subjects who make a blood donation of 400 ml within 12 weeks before the start of the intake or that of 200 ml within 4 weeks 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.

Related Information

• Primary Sponsor: Otsuka Pharmaceutical Co., Ltd
• Source(s) of Monetary Support: Otsuka Pharmaceutical Co., Ltd