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The Effects of Red Wine Polyphenols on Microvascular Dysfunction

The Effects of Red Wine Polyphenols on Microvascular Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01518764
Enrollment
29
Registered
2012-01-26
Start date
2012-05-31
Completion date
2014-11-30
Last updated
2014-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTRed Wine Polyphenols 600mg/day
DIETARY_SUPPLEMENTplacebo

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
insulin sensitivity as determined by euglycemic clamp tests8 weeks

Secondary

MeasureTime frame
Molecular mechanisms in muscle tissue8 weeks
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test8 weeks
microvascular function (baseline and during hyperglycemia)8 weeks
Blood pressure 24 hr measurement8 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026