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OpenTrials
Completed

NCT Number: NCT01518764

The Effects of Red Wine Polyphenols on Microvascular Dysfunction

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VUMedicalCenter

Amsterdam, North Holland, 1081 HV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Wine Polyphenols 600mg/day

Dietary Supplement

Other names: Provinols™

Placebo

Dietary Supplement

Primary outcomes

  1. insulin sensitivity as determined by euglycemic clamp tests

    Time frame: 8 weeks

Secondary outcomes

  1. Molecular mechanisms in muscle tissue

    Time frame: 8 weeks

  2. Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test

    Time frame: 8 weeks

  3. microvascular function (baseline and during hyperglycemia)

    Time frame: 8 weeks

  4. Blood pressure 24 hr measurement

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2012
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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