VUMedicalCenter
Amsterdam, North Holland, 1081 HV, Netherlands
NCT Number: NCT01518764
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Amsterdam, North Holland, 1081 HV, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Provinols™
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Time frame: 8 weeks
Amsterdam UMC, location VUmc
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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