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Risk/benefit ratio of polyphenols and ethanol contained in red wine
ISRCTN ISRCTN88720134
DOI 10.1186/ISRCTN88720134
ClinicalTrials.gov identifier
EudraCT number
Public title Risk/benefit ratio of polyphenols and ethanol contained in red wine
Scientific title Risk/benefit ratio of polyphenols and ethanol contained in red wine: a randomised, crossover, controlled clinical trial of the scientific basis of the effects of moderate consumption of red wine on cardiovascular system
Acronym N/A
Serial number at source AGL2006-14228-C03-01/ALI
Study hypothesis The benefit of the main components of red wine, namely ethanol and polyphenolic content is synergistic. No adverse events will be observed.

As of 23/05/2012, the target number of participants were updated from 125 to 73.
Lay summary Not provided at time of registration
Ethics approval Institutional Review Board of the Hospital Clinic of Barcelona approved
Study design Open randomised crossover controlled clinical trial
Countries of recruitment Spain
Disease/condition/study domain Arteriosclerosis
Participants - 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
Participants - 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
Anticipated start date 01/01/2007
Anticipated end date 01/01/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 73 (Target number of participants finally were 73 recruited and 6 withdrew before completing the study)
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 dealcoholised red wine

Initial wash-out period (15 days); 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 red wine
Intervention 3: 290 ml/day of dealcoholised red wine

Initial wash-out period (15 days); first intervention - 28 days; second intervention - 28 days and third intervention - 28 days.
Primary outcome measure(s) 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). 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 outcome measure(s) 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 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 administered by trained personnel. The foods ingested will be converted into nutritional values with the aid of the Professional Diet Balancer software (Cardinal Health Systems, Inc., Edina, MN). Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain. Control of the diet and physical exercise will be carried out before and after each intervention, the same day on which the clinical examinations are performed and blood is withdrawn for immunologic studies.

All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period.

Previous secondary outcome measure(s)
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. 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 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 administered by trained personnel. The foods ingested will be converted into nutritional values with the aid of the Professional Diet Balancer software (Cardinal Health Systems, Inc., Edina, MN). Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain. Control of the diet and physical exercise will be carried out before and after each intervention, the same day on which the clinical examinations are performed and blood is withdrawn for immunologic studies.

All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period.
Sources of funding Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación) (Spain) (ref: AGL2006-14228-C03-01/ALI)
Trial website
Publications
Contact name Dr  Ramon  Estruch
  Address Hospital Clinic de Barcelona
c/Villarroel nº170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
  Email restruch@clinic.ub.es
Sponsor Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)
  Address C/Albacete, 5
  City/town Madrid
  Zip/Postcode 28027
  Country Spain
  Sponsor website: http://web.micinn.es/
Date applied 06/04/2009
Last edited 18/12/2012
Date ISRCTN assigned 14/05/2009
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