Arteriosclerosis and its risk factors Circulatory System
Conditions
Interventions
Written material on the study protocol and the diet that should be followed by the subjects is administered at admission.
Acute study. Study of bioavailability and pharmacokinetics of tomato juices
Sponsors
Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación, MICINN) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute study. Healthy volunteers, body mass index between 18.5 and 24 Kg/m2, and no history of cardiovascular disease or haemostatic abnormalities. Chronic study. Hypertensive patients, male and female, between 55 and 80 years without documented cardiovascular disease (ischemic heart disease -angina pectoris or recent myocardial infarction or old-, stroke, or peripheral vascular disease), but who had two or more of the following cardiovascular risk factors: 1. Smoking, 2. Diabetes mellitus, 3. LDL-cholesterol > 160 mg/dl. 4. HDL-cholesterol 25 kg/m2). 6. Family history of premature ischemic heart disease.
Exclusion criteria
Exclusion criteria: Acute study. Previous history of cardiovascular disease (ischemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease), homeostatic disorders, any several chronic diseases, hypertension or dislipemia, smokers, alcoholism or other addiction, or allergy or intolerance to tomatoes . Chronic study. Healthy adults (males and females). Participants with previous history of cardiovascular disease, any severe chronic illness, alcoholism or other addiction, or allergy or intolerance to tomatoes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute study. a. Analysis of the antioxidants (vitamin C, carotenoids and phenolic compounds) in the tomato juices (with and without oil) administered to participants; b. Analysis of the antioxidant capacity (TEAC, ORAC, TRAP and FRAD), total phenolic concentration (Folin-Ciocalteu method) in plasma and urine samples; c. Analysis of polyphenols and their metabolites in plasma and urine samples of the participants by LC-MS/MS; d. Analysis of carotenoids and vitamins metabolites in plasma samples of the participants; e. Pharmacokinetic studies. Chronic study. a. Determination of the antioxidant content (vitamins C and, E, carotenoids and polyphenols of the juices used in the study, and its stability throughout the trial. b. Measurement of blood pressure, endothelial function, body weight, waist perimeter, glucose, insulin, HOMA index, lipid profile, and markers of oxidative stress, c. Study serum and cellular inflammatory biomarkers related to atherosclerosis, as well as study of adhesion of monocytes to an endothelial cell line. d. Analysis of carotenoids, vitamins, and polyphenols and their metabolites in plasma and urine samples. e. Genetic studies: genotyping of pre-selected SNPs and analysis of the association between SNPs and their corresponding phenotypes; gene expression analysis; analysis of whole genome expression; bioinformatic analysis of the gene expression results and validation of differentially expressed genes. Determinations reported in points b to e will be performed before and after each intervention. Evaluation of different doses of tomato juice on endothelial function and hypertension in high cardiovascular risk volunteers will be assessed in an open, controlled, randomized and cross-over feeding clinical trial following three interventions: (0 ml tomato juice (water)/day-control; 200 ml/day; 400 ml/day) for four weeks. Before and after each intervention the following measures will be taken: blood pressure, body weight, waist perimeter, glu | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute study and chronic study. a. In all participants a complete medical record before will be carried out entering to the study and data on dietary habits, alcohol consumption, smoking and physical activity will be recorded before and after each intervention (only in chronic study). b. Determination of carotenoids and polyphenols in plasma and urine before and after each intervention, that will also be used as an objective measurement of intervention compliance. c. In addition, in all volunteers all adverse events will be recorded and the following parameters will be measured: number of red and white cells, hematocrit, mean corpuscular volume, serum glucose, creatinine, electrolytes, uric acid, transaminases, lactate dehydrogenase, alkaline phosphatase, gammaglutamyl transpeptidase, bilirubin, creatinkinase and aldolase. | — |
Countries
Spain
Outcome results
None listed