The Effects of Red Wine Polyphenols on Microvascular Dysfunction

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Red Wine Polyphenols 600mg/day

• Registration Number: NCT01518764
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2012-05
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo (capsules)
Red Wine Polyphenols	Red Wine Polyphenols 600mg/day	Red Wine Polyphenols 600mg/day (capsules)

Primary Outcome Measures

Name	Time	Method
insulin sensitivity as determined by euglycemic clamp tests	8 weeks

Secondary Outcome Measures

Name	Time	Method
Blood pressure 24 hr measurement	8 weeks
Molecular mechanisms in muscle tissue	8 weeks
Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test	8 weeks
microvascular function (baseline and during hyperglycemia)	8 weeks

Trial Locations

Locations (1)

VUMedicalCenter; 🇳🇱 Amsterdam, Noord-Holland, Netherlands