Assessment of different doses of polyphenols from dealcoholized red wine and red wine on blood pressure and endothelial function in subjects with metabolic syndrome and high cardiovascular risk.

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN13583521
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bodegas Torres
• Public title: Assessment of different doses of polyphenols from dealcoholized red wine and red wine on blood pressure and endothelial function in subjects with metabolic syndrome and high cardiovascular risk.
• 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.
• Date of first enrolment: 01/10/2015
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13583521
• Study type: Interventional
• Study design: Dietary intervention trial, parallel, randomized, open and controlled (Prevention)

Countries of recruitment

Spain

Contacts

• Name: Rosa M. Lamuela-Raventós

Key inclusion & exclusion criteria

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)
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome (MeTS)
Nutritional, Metabolic, Endocrine

Intervention(s)

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).

Primary Outcome(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. 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(s)

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)

Secondary ID(s)

IRB00003099

Source(s) of Monetary Support

Ministerio de Economía y Competitividad, Biomedical Research Centre in Physiopathology of Obesity and Nutrition (Ciberobn)

Secondary Sponsor(s)

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

Ministry of Economy and Competitiveness