Condition category
Circulatory System
Date applied
07/09/2010
Date assigned
04/10/2010
Last edited
04/09/2014
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

Department of Internal Medicine
Hospital Clinic de Barcelona
c/Villarroel nº170
Barcelona
08036
Spain
+34 93 227 93 65
restruch@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Beer-01-2010

Study information

Scientific title

Scientific basis of beneficial effects of moderate beer consumption in the cardiovascular system: anti-inflammatory effects of alcohol and polyphenolic content of beer

Acronym

Study hypothesis

The benefit of the main components of beer, namely ethanol and polyphenolic content is synergistic. No adverse events will be observed.

Ethics approval

Institutional Review Board of the Hospital Clinic of Barcelona, 20/07/2010

Study design

Open randomised crossover controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Arteriosclerosis

Intervention

Intervention 1: 92 ml/day of gin (28 g ethanol/day)
Intervention 2: 660 ml/day of lager beer (28 g ethanol/day)
Intervention 3: 990 ml/day of dealcoholised lager beer (equivalent amount of polyphenols to 660 ml of beer)

Initial wash-out period (15 days)
First intervention - 28 days
Second intervention - 28 days
Third intervention - 28 days

Intervention type

Drug

Phase

Not Applicable

Drug names

Beer

Primary outcome measures

1. Endothelial function with a color Doppler Toshiba PowerVision ultrasound apparatus using multifrequency transducers (B-mode, 7.5 to 10 MHz; Doppler, 3.75 MHz).
2. 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).
3. 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)
4. Nuclear Factor Kappa B by western blot of peripheral blood mononuclear cells.
5. 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

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

01/10/2010

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males between 55 and 70 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. Diabetes mellitus, or three or more of the following risk 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

Adult

Gender

Male

Target number of participants

50

Participant 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

01/10/2010

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Department of Internal Medicine
Barcelona
08036
Spain

Sponsor information

Organisation

Cerveceros de España (Spain)

Sponsor details

C/ Almagro
24 2º Izqda
Madrid
28010
Spain

Sponsor type

Industry

Website

http://www.cerveceros.org/

Funders

Funder type

Industry

Funder name

Cerveceros de España (Spain)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24530788
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24477299
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25183453

Publication citations

  1. Results

    Chiva-Blanch G, Condines X, Magraner E, Roth I, Valderas-Martínez P, Arranz S, Casas R, Martínez-Huélamo M, Vallverdú-Queralt A, Quifer-Rada P, Lamuela-Raventos RM, Estruch R, The non-alcoholic fraction of beer increases stromal cell derived factor 1 and the number of circulating endothelial progenitor cells in high cardiovascular risk subjects: a randomized clinical trial., Atherosclerosis, 2014, 233, 2, 518-524, doi: 10.1016/j.atherosclerosis.2013.12.048.

  2. Results

    Quifer-Rada P, Martínez-Huélamo M, Chiva-Blanch G, Jáuregui O, Estruch R, Lamuela-Raventós RM, Urinary isoxanthohumol is a specific and accurate biomarker of beer consumption., J. Nutr., 2014, 144, 4, 484-488, doi: 10.3945/jn.113.185199.

  3. Results

    Chiva-Blanch G, Magraner E, Condines X, Valderas-Martínez P, Roth I, Arranz S, Casas R, Navarro M, Hervas A, Sisó A, Martínez-Huélamo M, Vallverdú-Queralt A, Quifer-Rada P, Lamuela-Raventos RM, Estruch R, Effects of alcohol and polyphenols from beer on atherosclerotic biomarkers in high cardiovascular risk men: A randomized feeding trial., Nutr Metab Cardiovasc Dis, 2014, doi: 10.1016/j.numecd.2014.07.008.

Additional files

Editorial Notes