UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063558 |
|---|---|
| Receipt number | R000072734 |
| Scientific Title | Effects of drinking diluted 'Hasaru-eki' deep sea water on vascular flexibility, microcirculation, and glycation in healthy older women: a cluster randomized controlled trial. |
| Date of disclosure of the study information | 2026/11/07 |
| Last modified on | 2026/11/07 19:14:46 |
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Basic information
Public title
Effects of drinking 'Hasaru-eki' deep sea water on vascular flexibility and microcirculation in older women.
Acronym
Effects of drinking 'Hasaru-eki' deep sea water on vascular flexibility and microcirculation in older women.
Scientific Title
Effects of drinking diluted 'Hasaru-eki' deep sea water on vascular flexibility, microcirculation, and glycation in healthy older women: a cluster randomized controlled trial.
Scientific Title:Acronym
Effects of drinking diluted 'Hasaru-eki' deep sea water on vascular flexibility, microcirculation, and glycation in healthy older women: a cluster randomized controlled trial.
Region
| Japan |
Condition
Condition
Healthy older women
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of drinking 500 ml/day of 'Hasaru-eki' deep sea water diluted 500-fold for 1 month on vascular flexibility, microcirculation, and glycation in healthy older women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Vascular flexibility and blood pressure measured with PASESA3, at baseline and after 1 month.
Key secondary outcomes
Microcirculation measured with a two-dimensional image measurement device, glycation (advanced glycation end products) measured with an AGE Scanner, and hemoglobin, vessel width and oxygen circulation measured with ASTRIM FIT, at baseline and after 1 month.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants drink 500 ml/day of 'Hasaru-eki' deep sea water diluted 500-fold with water for 1 month.
Interventions/Control_2
No intervention; participants continue their usual daily life.
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women aged 60 to 80 years.
Key exclusion criteria
Individuals with diseases that impair walking.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan
TEL
082-424-6844
shihok@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Kurosaka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan
TEL
082-424-6844
Homepage URL
shihok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan
Tel
082-424-6844
shihok@hiroshima-u.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
広島県内の公民館（広島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 07 | 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 | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 11 | Month | 07 | Day |
Last modified on
| 2026 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072734
