The Effects of Red Wine Polyphenols on Microvascular Dysfunction
NCT ID: NCT01518764
Last Updated: 2014-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2012-05-31
2014-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Red Wine Polyphenols
Red Wine Polyphenols 600mg/day (capsules)
Red Wine Polyphenols 600mg/day
placebo
placebo (capsules)
placebo
Interventions
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Red Wine Polyphenols 600mg/day
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-60 years
* obese (BMI \>30)
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Erik Serne
MD phd
Principal Investigators
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Erik Serne, MD PhD
Role: PRINCIPAL_INVESTIGATOR
VUmc, internal medicine
Locations
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VUMedicalCenter
Amsterdam, North Holland, Netherlands
Countries
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References
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Woerdeman J, Del Rio D, Calani L, Eringa EC, Smulders YM, Serne EH. Red wine polyphenols do not improve obesity-associated insulin resistance: A randomized controlled trial. Diabetes Obes Metab. 2018 Jan;20(1):206-210. doi: 10.1111/dom.13044. Epub 2017 Aug 14.
Other Identifiers
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NL37147.029.11
Identifier Type: -
Identifier Source: org_study_id