Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/07/2015
Date assigned
18/09/2015
Last edited
18/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Antioxidants are substances, natural or man-made, that may prevent or delay damage to the cells in our bodies. They are found in many foods, including fruit and vegetables. Polyphenols are the most abundant antioxidants in the diet and are found in a wide variety of foods in nature. One of the foods most rich in these compounds is wine. It has been considered that the biological effects of these compounds depend on their bioavailability (the amount of the compound made available to the body after digesting) and kinetics of its exposure time in the human body. Many studies have found that moderate wine drinkers have a lower cardiovascular mortality and a lower incidence of myocardial infarction and stroke, among others. The aim of this study is to assess the usefulness of phenolic metabolites as specific biomarkers of wine consumption and observe whether the ethanol increases the bioavailability of phenolic compounds.

Who can participate?
Participants between 55 and 80 years of age without a history of cardiovascular disease, any of several chronic diseases or an allergy/intolerance to and grape and wine. They should also have at least 3 of the following: high blood pressure (hypertension), high blood glucose levels or needing to use antidiabetic drugs/insulin, high blood triglyceride and cholesterol levels and a waist circumference of at least 102cm for men and 88cm for women.

What does the study involve?
Participants are randomly allocated into one of 4 groups. Those in group 1 are asked to drink 375 mL/day of extra water for three months. Those in group 2 are asked to drink 375 mL/day of dealcoholized red wine for three months. Those in group 3 are asked to drink 375 mL /day of dealcoholized red wine enriched with a grape extract for three months. Women in group 4 are asked to drink 130 mL/day of red wine. Men in group 4 are asked to drink 260 mL/day of wine for men for three months. All participants are requested to avoid consuming grape, wine and other alcoholized drinks for the 15 days leading up to the start of the study. All participants have a medical assessment is at the start and end of the study, which includes clinical history, dietary evaluation, anthropometric (body) measures, clinical blood pressure and 24-hour ambulatory blood pressure (that is, blood pressure taken over a 24 hour period as the participant goes about their daily activities), measurement of blood flow in brachial artery (major blood vessel in upper arm), full blood analysis (glucose, glycated hemoglobin, triglycerids, total cholesterol, HDLc, LDLc, lipoprotein (a)) and the collection of 24-hour urine sample.

What are the possible benefits and risks of participating?
There are no risks as long as the exclusion criteria are followed.

Where is the study run from?
The Department of Nutrition and Food Science of the University of Barcelona and the Department of Internal Medicine in the Hospital Clinic of Barcelona (Spain)

When is the study starting and how long is it expected to run for?
July 2015 to July 2016

Who is funding the study?
1. Ministry of Economy and Competitiveness, MINECO
2. Biomedical Research Centre in Physiopathology of Obesity and Nutrition (Ciberobn)

Main contact
Dr. Rosa Lamuela-Raventós

Trial website

Contact information

Type

Public

Primary contact

Dr Rosa M. Lamuela-Raventós

ORCID ID

http://orcid.org/0000-0002-1287-4560

Contact details

Food Science Department
Pharmacy Faculty
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRB00003099

Study information

Scientific title

Effects of bioactive compounds of dealcoholized red wine with two different polyphenol doses and red wine on blood pressure, biochemical parameters and cellular biomarkers related to atherosclerosis in subjects with metabolic syndrome. An open, randomized, parallel and controlled trial.

Acronym

POLYREDWIMES

Study hypothesis

Wine contains several phenolic compounds, which are known for its health benefits.

Aim 1: Compare the effects of consumption of dealcoholized red wine and dealcoholized red wine enriched with grape extract on anthropometric parameters, blood pressure, full blood analysis, levels of endothelial biomarkers and leukocyte cell-surface adhesion molecules in the subjects.

Aim 2: Compare the effects between dealcoholized red wine and regular alcoholized red wine on full blood analysis in subjects, anthropometric parameters, endothelial biomarkers, blood pressure and other cardiovascular risk factors.

Ethics approval

University of Barcelona is Jordi Alberch Viè, 11/12/2014, ref: IRB00003099

Study design

Dietary intervention trial, parallel, randomized, open and controlled

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Metabolic Syndrome (MeTS)

Intervention

Participants are randomly allocated into one of 4 groups.
Intervention 1: 375 mL/day of extra water for three months (ICT).
Intervention 2: 375 mL/day of dealcoholized red wine for three months (IVS).
Intervention 3: 375 mL /day of dealcoholized red wine enriched with a grape extract for three months (IVE).
Intervention 4: 130 mL/day of red wine for women and 260 mL/day of wine for men during three months (IVI).

Intervention type

Phase

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. Decrease in the endothelial adhesion molecules, chemokines and interleukins with the increase in phenolic content of the treatment (IVI > IVE > IVS > ICT).
3. Improvement of endothelial function in all interventions, measuring endothelial progenitor cells and circulating endothelial cells.
All variables (primary and secondary outcomes) will be measured at baseline and after each intervention period.

Secondary outcome measures

1. All participants in the study will be clinically examined and subsequently signed an informed consent according accept their participation in the study
2. At the beginning and end of each intervention period a medical assessment will be performed which included: clinical history, dietary evaluation, anthropometric measures, clinical blood pressure and 24-hour ambulatory blood pressure, measurement of blood flow in brachial artery, full blood analysis (glucose, glycated hemoglobin, triglycerids, total cholesterol, HDLc, LDLc, lipoprotein (a)) and the collection of 24-h urine sample.
3. A 7-day food record validated nutritional questionnaire will be used at the beginning and end of the intervention to assess nutrient intake and to monitor adherence to the dietary recommendations. We will use the Food Processor Nutrition & Fitness software. Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain
4. Bioavailability, identification and quantification polyphenols in plasma and urine to determine and compared new metabolites by LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS
5. Changes in urine metabolites (metabolomics)

Overall trial start date

01/09/2015

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Participants between 55 and 80 years of age and showed ≥ 3 of the following parameters that define the metabolic syndrome:
1. Hypertension (≥ 130/85 mm Hg or use of antihypertensive drugs)
2. Impaired glucose tolerance (glycemia ≥ 100 mg/dL or use of antidiabetic drugs and/or insulin)
3. Serum triglyceride concentration ≥150 mg/dL
4. Plasma HDL cholesterol concentrations ≤ 40 mg/dL (men), ≤ 50 mg/dL (women)
5. Waist circumference ≥ 102 cm (men), ≥ 88 cm (women)

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

80

Participant exclusion criteria

Healthy adults (males and females) or with:
1. Previous history of cardiovascular disease
2. Any several chronic diseases
3. Grape and wine intolerance or allergic
4. Alcoholism
5. Other toxic abuse

Recruitment start date

01/10/2015

Recruitment end date

31/07/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Department of Nutrition and Food Science of the University of Barcelona (Barcelona, Spain) and the Department of Internal Medicine in the Hospital Clinic of Barcelona.
Barcelona
08028
Spain

Sponsor information

Organisation

Bodegas Torres

Sponsor details

Vilafranca del Penedès
Barcelona
Barcelona
08720
Spain

Sponsor type

Industry

Website

http://www.torres.es/

Organisation

Biomedical Research Centre in Physiopathology of Obesity and Nutrition (Ciberobn)

Sponsor details

Instituto de Salud Carlos III
C/ Monforte de Lemos 3-5. Pabellón 11
Madrid
28029
Spain

Sponsor type

Research organisation

Website

www.ciberobn.es

Organisation

Ministry of Economy and Competitiveness

Sponsor details

Pº. de la Castellana nº 162
Madrid
28047
Spain

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Ministerio de Economía y Competitividad

Alternative name(s)

Ministry of Economy and Competitiveness, MINECO

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Funder name

Biomedical Research Centre in Physiopathology of Obesity and Nutrition (Ciberobn)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes