Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062468) titled 'Effects of Drinking Water at Different Temperatures on Thirst Sensation and Reduction of Physiological and Psychological Stress During Daily Activities in a Hot Environment' on Aug. 5.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - EUPHORIA Co., Ltd.
Condition:
Condition - Healthy Subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the effects of water intake at different temperatures on thirst sensation and the reduction of physiological and psychological stress.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of chilled water
Interventions/Control_2 - Intake of cool water
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Healthy males and females aged 20 to 59 years at the time of providing informed consent (target male-to-female ratio: 1:1).
Individuals whose self-reported height and weight yield a Body Mass Index (BMI) between 18.5 and 25.0 kg/m2 upon preliminary calculation.
Routinely active individuals with physical fitness and health status capable of completing approximately 60 minutes of total walking (equivalent to ~3 METs) with intermittent short breaks, without experiencing shortness of breath or body pain.
Individuals who do not experience severe shortness of breath or chest discomfort when climbing up and down stairs or walking briskly.
Individuals with no physician-imposed restrictions on daily physical activity or exertion in hot environments, and who currently have no orthopedic conditions or pain in the knees, lower back, ankles, etc., that interfere with walking.
Individuals who have received a thorough explanation of the study purpose, procedures, and potential risks, and are able to provide voluntary written informed consent.
Key exclusion criteria - Individuals currently undergoing treatment for any medical condition, or with a history of severe illness requiring medication (e.g., cardiovascular, respiratory, or metabolic disorders).
Individuals with a history of physician-diagnosed severe heat illness (Grade II or higher).
Individuals who have previously been informed by a physician of having vasovagal syncope (vasovagal reflex).
Individuals with a history of loss of consciousness following exercise.
Individuals with orthopedic complaints (e.g., lower back pain, knee pain) or a history of trauma that interferes with treadmill walking.
Individuals who routinely take medications or supplements that affect thermoregulation, circulatory function, or metabolism.
Individuals who currently smoke.
Individuals with skin disorders that interfere with the attachment of measurement devices.
Individuals judged inappropriate for participation in this study by the principal investigator or study physician due to health status, safety concerns, or other reasons.
Target Size - 14
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 30 Day
Date of IRB - 2026 Year 07 Month 30 Day
Anticipated trial start date - 2026 Year 08 Month 06 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071498
Disclaimer: Curated by HT Syndication.