Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effects of Red Wine Polyphenols on Microvascular Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
Erik Serne, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01518764
First received: January 2, 2012
Last updated: October 20, 2014
Last verified: October 2014

January 2, 2012
October 20, 2014
May 2012
December 2014   (final data collection date for primary outcome measure)
insulin sensitivity as determined by euglycemic clamp tests [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01518764 on ClinicalTrials.gov Archive Site
  • Molecular mechanisms in muscle tissue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Biomarkers such as lipoproteins, adipocytokines, and markers of systemic inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • microvascular function (baseline and during hyperglycemia) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure 24 hr measurement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Molecular mechanisms in muscle tissue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Biomarkers such as lipoproteins, adipocytokines, and markers of systemic inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Beta-cell function as determined by hyperglycemic clamp tests [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • microvascular function (baseline and during hyperglycemia) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure 24 hr measurement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effects of Red Wine Polyphenols on Microvascular Dysfunction
The Effects of Red Wine Polyphenols on Microvascular Dysfunction

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Dietary Supplement: Red Wine Polyphenols 600mg/day
    Other Name: Provinols™
  • Dietary Supplement: placebo
  • Experimental: Red Wine Polyphenols
    Red Wine Polyphenols 600mg/day (capsules)
    Intervention: Dietary Supplement: Red Wine Polyphenols 600mg/day
  • Placebo Comparator: placebo
    placebo (capsules)
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: E Serne, MD PhD e.serne@vumc.nl
Netherlands
 
NCT01518764
NL37147.029.11
Not Provided
Erik Serne, VU University Medical Center
VU University Medical Center
Not Provided
Principal Investigator: Erik Serne, MD PhD VUmc, internal medicine
VU University Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP