The Effects of Red Wine Polyphenols on Microvascular Dysfunction
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.
Randomized controlled trial (double blind).
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.
|Obesity||Dietary Supplement: Red Wine Polyphenols 600mg/day Dietary Supplement: placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effects of Red Wine Polyphenols on Microvascular Dysfunction|
- insulin sensitivity as determined by euglycemic clamp tests [ Time Frame: 8 weeks ]
- Molecular mechanisms in muscle tissue [ Time Frame: 8 weeks ]
- Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test [ Time Frame: 8 weeks ]
- microvascular function (baseline and during hyperglycemia) [ Time Frame: 8 weeks ]
- Blood pressure 24 hr measurement [ Time Frame: 8 weeks ]
|Study Start Date:||May 2012|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Red Wine Polyphenols
Red Wine Polyphenols 600mg/day (capsules)
Dietary Supplement: Red Wine Polyphenols 600mg/day
Other Name: Provinols™
Placebo Comparator: placebo
|Dietary Supplement: placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518764
|Amsterdam, Noord-Holland, Netherlands, 1081 HV|
|Principal Investigator:||Erik Serne, MD PhD||VUmc, internal medicine|