The Effects of Red Wine Polyphenols on Microvascular Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01518764
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : November 25, 2014
Information provided by (Responsible Party):
Erik Serne, VU University Medical Center

Brief Summary:


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


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.


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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Red Wine Polyphenols 600mg/day Dietary Supplement: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Red Wine Polyphenols on Microvascular Dysfunction
Study Start Date : May 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Red Wine Polyphenols
Red Wine Polyphenols 600mg/day (capsules)
Dietary Supplement: Red Wine Polyphenols 600mg/day
Other Name: Provinols™

Placebo Comparator: placebo
placebo (capsules)
Dietary Supplement: placebo

Primary Outcome Measures :
  1. insulin sensitivity as determined by euglycemic clamp tests [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01518764

Amsterdam, Noord-Holland, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
Principal Investigator: Erik Serne, MD PhD VUmc, internal medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Erik Serne, MD phd, VU University Medical Center Identifier: NCT01518764     History of Changes
Other Study ID Numbers: NL37147.029.11
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014