Condition category
Circulatory System
Date applied
06/04/2009
Date assigned
14/05/2009
Last edited
18/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ramon Estruch

ORCID ID

Contact details

Hospital Clinic de Barcelona
c/Villarroel nº170
Barcelona
08036
Spain
restruch@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGL2006-14228-C03-01/ALI

Study information

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

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.

Ethics approval

Institutional Review Board of the Hospital Clinic of Barcelona approved

Study design

Open randomised crossover controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Arteriosclerosis

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/01/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Male

Target number of participants

73 (Target number of participants finally were 73 recruited and 6 withdrew before completing the study)

Participant 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

Recruitment start date

01/01/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clinic de Barcelona
Barcelona
08036
Spain

Sponsor information

Organisation

Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)

Sponsor details

C/Albacete
5
Madrid
28027
Spain

Sponsor type

Government

Website

http://web.micinn.es/

Funders

Funder type

Government

Funder name

Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación) (Spain) (ref: AGL2006-14228-C03-01/ALI)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes