Clinical trial to investigate the effect of long-term intake of tomato juice on atherosclelosis

UMIN ID: UMIN000001173

Registered date:08/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Metabolic symdrome
• Date of first enrollment: 2008/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Long-term intake of tomato juice with lycopene
Long-term intake of tomato serum juice without lycopene

Outcome(s)

• Primary Outcome: Parameters of atherosclerosis (flow-mediated dilatation(FMD), blood endothelial progenitor cells (CD34/45/133/VEGFR), oxidized-LDL, inflammatory cytokines, highly-reactive CRP)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Tokushima University Hospital
• Source(s) of Monetary Support: Food Company