UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059006 |
|---|---|
| Receipt number | R000067486 |
| Scientific Title | Randomized Controlled Trial on the Hypotensive Effect of Water-Soluble Silicon |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/05 15:01:38 |
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Basic information
Public title
Randomized Controlled Trial on the Hypotensive Effect of Water-Soluble Silicon
Acronym
Randomized Controlled Trial on the Hypotensive Effect of Water-Soluble Silicon
Scientific Title
Randomized Controlled Trial on the Hypotensive Effect of Water-Soluble Silicon
Scientific Title:Acronym
Randomized Controlled Trial on the Hypotensive Effect of Water-Soluble Silicon
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Social interest in functional foods aimed at preventing and improving lifestyle-related diseases is growing. Particularly, the efficacy of food components (water-soluble silicon) believed to have blood pressure-lowering effects is drawing attention as a non-pharmacological intervention for blood pressure control.
This study aims to verify the effects of continuous 12-week intake of water-soluble silicon on blood pressure in adults with prehypertension or stage I hypertension through a placebo-controlled, randomized, double-blind, crossover trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure measurement, questionnaire, blood test (biochemical test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention period: 12 weeks
Intervention details: Consumption of water-soluble silicon water or placebo (distilled water with identical appearance) three times daily (3 ml per dose)
Interventions/Control_2
Intervention period: 12 weeks
Intervention details: Placebo (distilled water identical in appearance to water-soluble silicon water) administered three times daily (3 ml per dose)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Age: Healthy adult men and women
- Individuals with screening blood pressure readings within the following ranges:
- SBP: 159 mmHg or lower OR
- DBP: 99 mmHg or lower
- Individuals who have received an explanation and signed the consent form of their own free will.
Key exclusion criteria
- SBP 160 mmHg or higher OR DBP 100 mmHg or higher
- Individuals with a BMI below 15 or a BMI of 25 or higher
- Individuals currently receiving treatment from a physician, including antihypertensive medication
- Individuals who are pregnant, breastfeeding, or may be pregnant
- Individuals with allergies to food ingredients
- Individuals with psychiatric disorders or cognitive impairment making informed consent difficult
- Other individuals deemed unsuitable by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daiki |
| Middle name | |
| Last name | Jimbo |
Organization
Reiwa Medical Research Co., Ltd.
Division name
Medical Research Institute
Zip code
2200023
Address
401, 2-7-20 Hiranuma, Nishi Ward, Yokohama City, Kanagawa Prefecture
TEL
0452981570
info@rmr.co.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Jimbo |
Organization
Reiwa Medical Research Co., Ltd.
Division name
Medical Research Institute
Zip code
2200023
Address
401, 2-7-20 Hiranuma, Nishi Ward, Yokohama City, Kanagawa Prefecture
TEL
0452981570
Homepage URL
info@rmr.co.jp
Sponsor or person
Institute
Reiwa Medical Research Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
APA Corporation Co.,Ltd.
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
Ethics Review Committee of Japanese medical association of Healthcare Products
Address
2-51-202 Kyoshin-cho, Minami Ward, Yokohama City, Kanagawa Prefecture
Tel
0452981570
info@yhd.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 | 09 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067486
