Arteriosclerosis and endothelial function Circulatory System Atherosclerosis
Conditions
Interventions
Run-in period (15d)
intervention A - 21d
15d wash-out and intervention B -21d. Before each intervention, 0.5g OH/Kg will be administered as gin or wine.
Intervention 1: 92 ml/day of gin
Intervention 2: 255 ml/day of aged wine
Acute phase
Sponsors
Spanish Foundation for the Wine and Nutrition Research (Fundación para la Investigación del Vino y Nutrición FIVINN) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 55 and 80 years old without documented cardiovascular disease (ischaemic heart disease ? angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease) and who have diabetes mellitus or three or more of the following factors: 1.1. Current smoking 1.2. Hypertension 1.3. Hypercholesterolemia [LDL-cholesterol > 160 mg/dl, HDL-cholesterol 25 kg/m2) and/or 1.5. Family history of premature coronary heart disease 2. Healthy males and females between 20 and 40 years 3. The participant should give signed informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with a previous history of cardiovascular disease (ischaemic heart disease ? angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease) 2. Any severe chronic disease 3. Alcoholism or other toxic abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Leukocyte adhesion molecule expression Lymphocyte and monocyte adhesion molecules on these cells will be marked with monoclonal antibodies (MAb) conjugated with fluorescein-isothiocyanate (FITC) and phycoerythrin (PE) by direct double immunofluorescence. The MAb of the adhesion molecules used will be: anti-CD11a (LFA-1), anti-CD40L, anti-CD11b (Mac-1) (Bender MedSystems Diagnostics, Vienna), anti-Syalil Lewis (anti-CD15s) (Pharmingen, San Diego, CA), anti-CD49d (VLA-4) (Cytogmos) and CD31 (BD, NJ, USA). The monoclonal antibodies used to mark the T-lymphocytes will be anti-CD2 and monocytes, anti-CD14 (Caltag Laboratories, Burlingame, CA). 2. Soluble adhesion molecules The following serum soluble adhesion molecules will be determined by ELISA kits: 2.1. sICAM-1, sVCAM-1, PECAM, hs-CRP, sE-selectin, and sP-selectin, as well as sMCP-1, TNF-a, IL-6 and IL-1B (Immunotech). 2.2. Nuclear Factor Kappa B by western blot of peripheral blood mononuclear cells. 2.3. Genes and proteins involved in inflammatory response will be determined by real time PCR and Western blot analysis (MCP-1, TF and TFPI, as markers of inflammation and LRP and the LDL receptor as lipoproteic receptors). Moreover, the expression metalloproteases and their activity will also be analyzed. 3. Oxidative stress The following plasma molecules will be determined: superoxide dismutase (SOD) with the Superoxide Dismutase Assay SD125 (Randox Laboratories Ltd, UK), catalase (CAT) with the Catalase Assay (Cayman Chemical, Ann Arbor, MI, USA), glutathione reductase (GR) and reduced glutathione (GSH) with the Glutathione Reductase Assay GR2368 (Randox Laboratories Ltd, UK), glutation peroxidase with the RS 504 assay (Randox Laboratories Ltd, UK), el complejo GSH/GSSG (Bioxytech OxisResearch, Foster City, CA, USA), protein carbonyl groups with the Protein Carbonyl Assay (Cayman Chemical, Ann Arbor, MI, USA), lipid peroxides (LPO) with the LPO-CC Assay (Kamiya Biomedical Company, Seattle, USA), malondia | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medical record A complete medical record will be obtained from all participants, which included data on alcohol intake, smoking and dietary habits. Blood pressure and heart rate will be measured with an electronic apparatus Omron HEM-705CP (Netherlands). 2. Nutrition assessment and general analyses All participants will complete a validated nutritional questionnaire at baseline to determine the total quantity of calories ingested in the previous month as well as the proportion corresponding to carbohydrates, lipids and proteins by using the Food Processor Nutrition & Fitness software (esha RESEARCH, Salem, OR, USA) . Overall nutrition will be determined by percentage of ideal weight, lean body mass and body mass index. Waist Perimeter will be measured. The proteic nutrition will be determined on the basis of the following parameters: hemoglobin, total lymphocyte count, total proteins, albumin, prealbumin, transferrin and retinol-binding protein. Serum and intraerythrocytary folic acid concentrations will be measured, as well as serum vitamin A, B1, B12, C, E, B-carotenes, Zn, Mg and Se concentrations. Moreover, the following measurements will also be obtained: red blood cell count, hematocrit, mean corpuscular volume, leukocyte count, glucose, creatinine, electrolytes, uric acid, transaminases, lactate dehydrogenase, alkaline phosphatase, gammaglutamyl transpeptidase and bilirrubin. 3. Coagulation tests The following parameters will also be determined: platelet count, prothrombin time, and plasma fibrinogen. 4. Serum lipoproteins and others Total cholesterol, triglycerides, cHDL, cLDL, Apo A1, Apo B, lipoprotein (a) and homocysteine will be determined. 5. Diet and exercise monitoring All participants will follow an isocaloric diet prepared according to their personal preferences. The diet will be strictly monitored during the study. Diet compliance will be assessed from 7-days diet records administered before each evaluation. This assessment will be adm | — |
Countries
Spain
Outcome results
None listed