The Effects of Red Wine Polyphenols on Microvascular Dysfunction

November 24, 2014 updated by: Erik Serne, Amsterdam UMC, location VUmc

Rationale:

Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce

Objective:

To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.

Study design:

Randomized controlled trial (double blind).

Study population:

Obese (BMI >30); n=30, men or women, aged 18-60 years.

Intervention:

Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VUMedicalCenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Caucasian
  • age 18-60 years
  • obese (BMI >30)

Exclusion Criteria:

  • cardiovascular disease
  • smoking
  • diabetes mellitus
  • recent history (<12 months) of high alcohol use > 4 U/day
  • use of medication potentially affection insulin sensitivity or microvascular function
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Red Wine Polyphenols
Red Wine Polyphenols 600mg/day (capsules)
Dietary supplement: Red Wine Polyphenols 600mg/day
Other Names:
  • Provinols™
PLACEBO_COMPARATOR: placebo
placebo (capsules)
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin sensitivity as determined by euglycemic clamp tests
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Molecular mechanisms in muscle tissue
Time Frame: 8 weeks
8 weeks
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test
Time Frame: 8 weeks
8 weeks
microvascular function (baseline and during hyperglycemia)
Time Frame: 8 weeks
8 weeks
Blood pressure 24 hr measurement
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Erik Serne, MD PhD, VUmc, internal medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (ESTIMATE)

January 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NL37147.029.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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