Metabolic symdrome
Conditions
Interventions
Long-term intake of tomato juice with lycopene
Long-term intake of tomato serum juice without lycopene
Sponsors
Tokushima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Is over 50 years old and meets at least one of the followings; Serum triglycerides >= 150mg/dl and/or serum HDL-cholesterol< 40mg/dl, Systolic blood pressure >= 130mmHg and/or diastolic blood pressure >= 85mmHg, FBS >= 110mg/dl and/or BS >= 140mg/dl and/or HbA1c >= 5.8% 2) To whom follow up will be possible in out-patient clinic or in other appropriate ways for 9 months 3) No alterations will be required for the medication for hypertension, lipid disorder and/or diabetes mellitus in the study period
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters of atherosclerosis (flow-mediated dilatation(FMD), blood endothelial progenitor cells (CD34/45/133/VEGFR), oxidized-LDL, inflammatory cytokines, highly-reactive CRP) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactChiho Sato
Tokushima University Hospital Clinical Trial Center for Developmental Therapeutics
Outcome results
None listed