UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057980 |
|---|---|
| Receipt number | R000066157 |
| Scientific Title | Effects of Water Ingestion on Hemodynamics During Orthostatic Stress |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/05/27 12:34:56 |
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Basic information
Public title
Can Drinking Water While Standing Reduce Blood Pressure Drops?
Acronym
"Blood Pressure Changes Associated with Drinking Water While Standing
Scientific Title
Effects of Water Ingestion on Hemodynamics During Orthostatic Stress
Scientific Title:Acronym
Hemodynamic Response to Water Intake During Orthostasis
Region
| Japan |
Condition
Condition
Normal Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Drinking room temperature water causes a transient increase in blood pressure (pressor response). This phenomenon is also observed in healthy individuals and disappears immediately after drinking (Endo et al., JJPysiol 2002). It is believed to be associated with the stimulation of mechanoreceptors due to the contraction of swallowing-related muscles (Abe et al., J. Appl. Physiol 2013).
In a previous study involving healthy subjects, we demonstrated that drinking 200 mL of cold water or cold carbonated water enhanced the pressor response during ingestion compared to room temperature water, and that this pressor response was sustained. This suggested that drinking cold or cold carbonated water might be useful for improving and preventing orthostatic hypotension (Kubota et al., Front. Neurol 2022). It was further suggested that this pressor response during drinking is modulated by cold and carbonation stimuli, and that the sustained pressor response post-ingestion might be triggered by a decrease in core body temperature. Notably, mean blood pressure during cold water ingestion increased by over 15 mmHg in young adults and over 20 mmHg in older adults.
However, that study was conducted with participants in a resting seated position, and it remains unknown whether a similar beneficial pressor response can be elicited during an orthostatic challenge.
Therefore, the purpose of this study is to investigate whether a similar pressor effect can be achieved during an orthostatic challenge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Pressure
Key secondary outcomes
Heart Rate, Stroke Volume, Cardiac Output, Systemic Vascular Resistance, Respiratory Sinus Arrhythmia, Baroreflex Sensitivity, Core Temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
No intervention; after 10 minutes of supine rest, participants underwent a 15-minute standing challenge, followed by 5 minutes of supine rest again.
Interventions/Control_2
200mL of water at approximately 37 degree; After 10 minutes of supine rest, a 15-minute standing challenge is performed (with 1 minute of drinking water after 5 minutes of standing), followed by another 5 minutes of supine rest.
Interventions/Control_3
200mL of water at approximately 4 degree; After 10 minutes of supine rest, a 15-minute standing challenge is performed (with 1 minute of drinking water after 5 minutes of standing), followed by another 5 minutes of supine rest.
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
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
Participants will be healthy young adults, aged 18 to 24 years at the time of consent, who are capable of providing their own written informed consent.
Key exclusion criteria
1 Individuals with current or past history of diseases affecting the respiratory, cardiovascular, digestive, renal, or autonomic nervous systems.
2 Individuals with abnormalities identified in a health check-up, such as an abnormal electrocardiogram (ECG) or hypertension.
3 Individuals who are pregnant or may be pregnant.
4 Individuals unable to provide voluntary informed consent.
Target sample size
19
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, Shiroyama, Odawara-city, Kanagawa, JAPAN
TEL
0465216500
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, Shiroyama, Odawara-city, Kanagawa, JAPAN
TEL
0465216500
Homepage URL
satoshi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
MEXT
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, Shiroyama, Odawara-city, Kanagawa, JAPAN
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
| 2025 | Year | 05 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066157
