Tokyo, Sept. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059006) titled 'Randomized Controlled Trial on the Hypotensive Effect of Water-Soluble Silicon' on Sept. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Reiwa Medical Research Co., Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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)

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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067486

Disclaimer: Curated by HT Syndication.