Arteriosclerosis Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
Current interventions as of 23/05/2012
Intervention 1: 100 ml/day of gin
Intervention 2: 272 ml/day of red wine
Intervention 3: 272 ml/day of dealcoholi
first intervention - 28 days
second intervention - 28 days and third intervention - 28 days.
Previous interventions
Intervention 1: 100 ml/day of gin
Intervention 2: 290 ml/day of
second intervention - 28 days and third intervention - 28 days.
Sponsors
Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males between 55 and 80 years old 2. No documented cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease) 3. Have diabetes mellitus or three or more of the following factors: 3.1. Current smoking 3.2. Hypertension 3.3. Hypercholesterolaemia (low density lipoprotein [LDL]-cholesterol greater than 160 mg/dl) 3.4. High density lipoprotein (HDL)-cholesterol less than 40 mg/dl 3.5. Overweight or obese (body mass index greater than 25 kg/m^2) 3.6. Family history of premature coronary heart disease 4. Participant gives signed informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/05/2012 1. 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 4. Other toxic abuse 5. Human immunodeficiency virus infection 6. Malnutrition 7. Acute infectious diseases 8. Customary use of vitamin supplements Previous exclusion criteria 1. 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 4. 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-Sialyl Lewis (anti-CD15s) (Pharmingen, San Diego, CA), anti-CD49d (VLA-4) (Cytogmos). 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 enzyme-linked immunosorbent assay (ELISA) kits: soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular adhesion molecule 1 (sVCAM-1), sE-selectin, and sP-selectin, as well as soluble monocyte chemotactic protein-1 (sMCP-1), tumour necrotising factor-alpha (TNF-a), and interleukin B (IL-1B) (Immunotech) 3. Nuclear Factor Kappa B by western blot of peripheral blood mononuclear cells 4. Genes and proteins involved in inflammatory response will be determined by real time polymerase chain reaction (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 analysed. All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s) as of 23/05/2012 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). Plasma nitric oxide will be measured by a chemiluminescence detector in a NO analyzer (Sievers Instruments, Inc., Boulder, CO). 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. 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: haemoglobin, 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, gamma-glutamyl transpeptidase and bilirubin. 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 A2, Apo B, Apo C1, Apo C2, lipoprotein (a), insulin, adiponectin, growth hormone, leptin and homocysteine will be determined. 5. Diet and exercise monitoring: all participants will follow an isoca | — |
Countries
Spain
Outcome results
None listed