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Clinical Trials/NCT01518764
NCT01518764
Completed
Not Applicable

The Effects of Red Wine Polyphenols on Microvascular Dysfunction

Amsterdam UMC, location VUmc1 site in 1 country29 target enrollmentMay 2012
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Amsterdam UMC, location VUmc
Enrollment
29
Locations
1
Primary Endpoint
insulin sensitivity as determined by euglycemic clamp tests
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Erik Serne

MD phd

Amsterdam UMC, location VUmc

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

insulin sensitivity as determined by euglycemic clamp tests

Time Frame: 8 weeks

Secondary Outcomes

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

Study Sites (1)

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