UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049475 |
|---|---|
| Receipt number | R000054643 |
| Scientific Title | Effects of water volume and temperature on the pressor response to drinking water |
| Date of disclosure of the study information | 2022/11/11 |
| Last modified on | 2023/12/04 23:45:43 |
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Basic information
Public title
Effects of water volume and temperature on the pressor response to drinking water
Acronym
The pressor response in drink water
Scientific Title
Effects of water volume and temperature on the pressor response to drinking water
Scientific Title:Acronym
The pressor response in drink water
Region
| Japan |
Condition
Condition
healthy young adult/ healthy elderly
Classification by specialty
| Cardiology | Geriatrics | Rehabilitation medicine |
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A transient increase in blood pressure (elevated pressure) occurs when drinking room temperature water. This pressure increase can be observed even in normal subjects and disappears immediately after drinking (Endo et al., 2002). It is believed to be related to stimulation of mechanoreceptors associated with contraction of swallowing-related muscles (Abe et al., 2013). On the other hand, autonomic neuropathy patients and the elderly are known to experience elevated pressure after drinking water (Jordan et al., 2000). It has been suggested that this is due to the hypoosmolality associated with drinking water, which activates sympathetic nerve activity and causes hypertension (Brown et al., 2005). Most of these drinking experiments have been conducted with approximately 500 mL of water.
In our experiments on healthy subjects, we showed that drinking 200 mL of cold or cold carbonated water increased and maintained the elevated pressure during drinking compared to room temperature water (Kubota et al., 2022). This pressure increase during drinking may be decorated by cooling or carbonation stimuli, and the sustained pressure increase after drinking may be caused by a decrease in nuclear core temperature. In particular, the mean blood pressure elevation during drinking of cold water was 15 mmHg in young subjects and over 20 mmHg in elderly subjects.
In the present study, based on our previous studies, we will examine the conditions for BP elevation with even smaller amounts of drinking water and under different temperature conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Diastolic blood pressure
Mean blood pressure
Key secondary outcomes
Heart rate
Baroreflex sensitivity
Respiratory sinus arrhythmia
Arterial Velocity pulse Index
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In a sitting position, the subject drinks 200 mL of water at approximately 38degree Celsius with a feeding tube in his/her mouth. The order of each drinking condition will be randomized and performed on different days.
Interventions/Control_2
In a sitting position, the subject drinks 200 mL of water at approximately 4degree Celsius with a feeding tube in his/her mouth.
Interventions/Control_3
In a sitting position, the subject drinks 200 mL of water at approximately 50degree Celsius with a feeding tube in his/her mouth.
Interventions/Control_4
In a sitting position, the subject drinks 100 mL of water at approximately 38degree Celsius with a feeding tube in his/her mouth.
Interventions/Control_5
In a sitting position, the subject drinks 100 mL of water at approximately 4degree Celsius with a feeding tube in his/her mouth.
Interventions/Control_6
In a sitting position, the subject drinks 100 mL of water at approximately 50degree Celsius with a feeding tube in his/her mouth.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participation in the study was based on free and voluntary consent. Participants were healthy individuals who were able to obtain informed consent in writing and whose age was 18 years or older.
Key exclusion criteria
Persons with respiratory, circulatory, gastrointestinal, renal, or autonomic nervous system diseases and those with a history of such diseases are excluded. Persons who have difficulty in obtaining a written consent of their own free will are also excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | kubota |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Odawara
Zip code
250-8588
Address
1-2-25,Jouyama,Odawara-shi,Kanagawa
TEL
0465-21-6500
satoshi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | kubota |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Odawara
Zip code
250-8588
Address
1-2-25,Jouyama,Odawara-shi,Kanagawa
TEL
0465-21-6500
Homepage URL
satoshi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-2-25,Jouyama,Odawara-shi,Kanagawa
Tel
0465-21-6500
satoshi@iuhw.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
| 2022 | Year | 11 | Month | 11 | 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
15
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The experiment was repeatedly interrupted due to COVID-19, resulting in delays.
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054643
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