Study evaluating the effects of GOZEN BIOMATCHA® on vascular health

A single-center, prospective, randomized, double-blind, two-arm, parallel-group, placebo-controlled clinical trial to evaluate the efficacy of GOZEN BIOMATCHA® on vascular endothelial function (SPG-derived reactive hyperemia), conduit artery dilation (FMD/NMD), nitric oxide metabolites, inflammatory biomarkers, lipid profile, and oral microbiome composition over 4 weeks in middle-aged adults with mild subclinical cardiovascular dysfunction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10201070

Enrollment

Registered

2026-03-12

Start date

2025-09-10

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild subclinical cardiovascular dysfunction Circulatory System

Interventions

Participants are randomized in a 1:1 allocation ratio to receive either GOZEN BIOMATCHA® or a matched placebo in a double-blind, parallel-group design. Block randomization are used to allocate partici

Eligibility

Sex/Gender

All

Age

35 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 35–55 years 2. Body mass index (BMI) 19.0–30.0 kg/m² 3. Reduced endothelial vasoreactivity (=5.0 ml/100 ml tissue/min by SPG) 4. Low-density lipoprotein (LDL) >120 mg/dl and/or triglycerides >150 mg/dl 5. No diagnosed cardiovascular disease requiring pharmacological treatment 6. Not using medications affecting vascular function 7. Able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Diagnosed cardiovascular disease 2. Uncontrolled hypertension (=160/100 mmHg) 3. Diabetes mellitus 4. Hepatic, renal, or GI disease 5. Active inflammatory or infectious disease 6. Use of lipid-lowering or vascular medications 7. Pregnancy or breastfeeding 8. Substance abuse 9. Recent participation in another clinical trial

Countries

Switzerland

Contacts

Public ContactAki Honda

development@innovationlabo.com+81 (0)3-35525335

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026