The Effects of Red Wine Polyphenols on Microvascular Dysfunction
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|ClinicalTrials.gov Identifier: NCT01518764|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : November 25, 2014
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.
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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|
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01518764
|Amsterdam, Noord-Holland, Netherlands, 1081 HV|
|Principal Investigator:||Erik Serne, MD PhD||VUmc, internal medicine|