Study evaluating the effects of GOZEN BIOMATCHA® on vascular health
| ISRCTN | ISRCTN10201070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10201070 |
| Sponsor | Gozen Biotech |
| Funder | Gozen Biotech |
- Submission date
- 02/03/2026
- Registration date
- 12/03/2026
- Last edited
- 12/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Endothelial dysfunction is an early sign of cardiovascular disease. GOZEN BIOMATCHA® is a matcha-based supplement developed to support vascular health. This study evaluates its effect on blood vessel function, nitric oxide levels, inflammation, lipid profile, and oral microbiome composition over 4 weeks.
Who can participate?
Men and women aged 35–55 years with mild cardiovascular risk factors but no diagnosed cardiovascular disease.
What does the study involve?
Participants take either GOZEN BIOMATCHA® or placebo tablets daily for 4 weeks. Vascular tests, blood tests, and oral swabs are collected at baseline and Week 4.
What are the possible benefits and risks of participating?
Participants may experience improvements in vascular function and cardiometabolic markers. Risks are minimal and include possible mild supplement-related adverse events. Safety is monitored via clinical exams and laboratory testing.
Where is the study run from?
Gozen Biotech (Japan)
When is the study starting and how long is it expected to run for?
September 2025 to November 2025
Who is funding the study?
Gozen Biotech (Japan)
Who is the main contact?
Mrs Aki Honda, development@innovationlabo.com
Contact information
Public
Shintomi HJ bldg 5F, 1-12-7
Shintomi-Cho
Chuo-ku
104-0041
Japan
| Phone | +81 (0)3-35525335 |
|---|---|
| development@innovationlabo.com |
Principal investigator
Hegenheimermattweg 167A
Allschwil
4123
Switzerland
| Phone | +41 (0)798114783 |
|---|---|
| innovation@swiss-biome.com |
Scientific
Shintomi HJ bldg 5F, 1-12-7 Shintomi
Chuo-ku
104-0041
Japan
| Phone | +81 (0)3-35525335 |
|---|---|
| innovationmika@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | 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 |
| Study objectives | |
| Ethics approval(s) |
Approved 13/05/2025, Swiss Association of Anti-Aging Nutrition (Löwenstrasse 11, Zurich, 8001, Switzerland; +41 (0)7811 47 83; rfaber.saan@gmail.com), ref: 2025/05-THS246 |
| Health condition(s) or problem(s) studied | Mild subclinical cardiovascular dysfunction |
| Intervention | 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 participants to each group. GOZEN BIOMATCHA® is a proprietary matcha-based dietary supplement formulated as oral tablets. Each tablet contains 300 mg of the active formulation. Participants assigned to the active arm consume four tablets daily (total daily dose 1,200 mg) for a duration of 4 weeks. The placebo consists of inert excipients matched in appearance, weight, taste, and packaging to maintain blinding integrity. The investigational product and placebo are administered orally and taken daily for 4 consecutive weeks. Compliance is assessed through tablet count and subject self-report. All efficacy and safety assessments are conducted at baseline (Week 0) and at the end of the intervention period (Week 4). |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 20/11/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/09/2025 |
| Date of final enrolment | 30/09/2025 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
02/03/2026: Study's existence confirmed by the Swiss Association of Anti-Aging Nutrition.
