Clinical trial to investigate the effect of long-term intake of tomato juice on atherosclelosis
Phase 2
- Conditions
- Metabolic symdrome
- Registration Number
- JPRN-UMIN000001173
- Lead Sponsor
- Tokushima University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Has a history of malignant diseases and/or present malignant diseases 2) To whom pharmaceutical agents should be considered for hypertension, lipid disorder and/or diabetes mellitus 3) Has a overt systemic disease 4) Has a history of allergy to tomato 5) Has a history of cardiovascular events (cerebrovascular diseases, ischemic heart disease), has been receiving anti-platelet agents, anti-coagrants 6) Is a participant in other clinical trial 7) Is not appropriate in the investigators' opinion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters of atherosclerosis (flow-mediated dilatation(FMD), blood endothelial progenitor cells (CD34/45/133/VEGFR), oxidized-LDL, inflammatory cytokines, highly-reactive CRP)
- Secondary Outcome Measures
Name Time Method 1) Serum total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol 2) FBS, HbA1c 3) Blood pressure, body weight, body fat parcentage, waist, BMI 4) Biomarkers; serum carotenoids, urine 8-OHdG, isoprostane, PAI-1, TNF-alfa, adiponectin