UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062468 |
|---|---|
| Receipt number | R000071498 |
| Scientific Title | Effects of Drinking Water at Different Temperatures on Thirst Sensation and Reduction of Physiological and Psychological Stress During Daily Activities in a Hot Environment |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/04 18:00:12 |
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Basic information
Public title
Effects of Drinking Water at Different Temperatures on Thirst Sensation and Reduction of Physiological and Psychological Stress During Daily Activities in a Hot Environment
Acronym
Effects of Drinking Water at Different Temperatures on Thirst Sensation and Reduction of Physiological and Psychological Stress During Daily Activities in a Hot Environment
Scientific Title
Effects of Drinking Water at Different Temperatures on Thirst Sensation and Reduction of Physiological and Psychological Stress During Daily Activities in a Hot Environment
Scientific Title:Acronym
Effects of Drinking Water at Different Temperatures on Thirst Sensation and Reduction of Physiological and Psychological Stress During Daily Activities in a Hot Environment
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thirst
Key secondary outcomes
Tympanic temperature
Heart rate
Urine specific gravity
Body weight
Refreshment
Thermal sensation
Thermal comfort
Fatigue
Water intake volume
Ease of drinking
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of chilled water
Interventions/Control_2
Intake of cool water
Interventions/Control_3
Intake of room temperature water
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | 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 sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Fuminori |
| Middle name | |
| Last name | Takayama |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
fuminori.takayama@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
Homepage URL
yuki.urushizawa@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Fuminori Takayama
Funding Source
Organization
THERMOS K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071498
