UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058047 |
|---|---|
| Receipt number | R000066229 |
| Scientific Title | Effect of cold water consumption on body temperature and autonomic nervous system activity in subjects with cold constitution |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/05 08:09:07 |
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Basic information
Public title
Effect of cold water consumption on body temperature and autonomic nervous system activity in subjects with cold constitution
Acronym
Effect of cold water consumption on body temperature and autonomic nervous system activity in subjects with cold constitution
Scientific Title
Effect of cold water consumption on body temperature and autonomic nervous system activity in subjects with cold constitution
Scientific Title:Acronym
Effect of cold water consumption on body temperature and autonomic nervous system activity in subjects with cold constitution
Region
| Japan |
Condition
Condition
cold constitution
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of cold water on body temperature and autonomic nervous system activity in subjects with cold constitution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra-aural temperature
Skin temperatures of finger and toe
Key secondary outcomes
Autonomic nervous activities by heart rate variability power spectral analysis
Heart rate
Thermal sensation by visual analogue scales
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single intake of 37 degrees Celsius water
Interventions/Control_2
A single intake of 10 degrees Celsius water
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Female college students with cold constitution
Key exclusion criteria
Subjects whose BMI is more than 25
Smoker
Subjects who have heart disease or metabolic disease
Subjects who have irregular menstrual cycle
Pregnant women
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Midoh |
Organization
Tokyo Healthcare University
Division name
Division of Medical Nutrition, Faculty of Healthcare
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo, Japan
TEL
0357993711
n-mido@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Midoh |
Organization
Tokyo Healthcare University
Division name
Division of Medical Nutrition, Faculty of Healthcare
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo, Japan
TEL
0357993711
Homepage URL
n-mido@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Healthcare University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Healthcare University
Address
4-1-17 Higashigotanda, Shinagawa-ku, Tokyo, Japan
Tel
0354217655
rinri@thcu.ac.jp
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
| 2025 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066229
