NIPH Clinical Trials Search

UMIN ID: UMIN000001173

Registered date:08/06/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMetabolic symdrome
Date of first enrollment2008/06/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Long-term intake of tomato juice with lycopene Long-term intake of tomato serum juice without lycopene


Primary OutcomeParameters of atherosclerosis (flow-mediated dilatation(FMD), blood endothelial progenitor cells (CD34/45/133/VEGFR), oxidized-LDL, inflammatory cytokines, highly-reactive CRP)
Secondary Outcome1) 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 minimum50years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Chiho Sato
Address 2-50-1 Kuramoto-cho, Tokushima Japan
Telephone 088-633-9294
Affiliation Tokushima University Hospital Clinical Trial Center for Developmental Therapeutics
scientific contact
Name Masashi Akaike
Address 2-50-1 Kuramoto-cho, Tokushima Japan
Telephone 088-633-7851
Affiliation Tokushima University Hospital Department of Cardiovascular Medicine