The Effects of Red Wine Polyphenols on Microvascular Dysfunction

Obesity Clinical Trial

Official title:

The Effects of Red Wine Polyphenols on Microvascular Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518764
• Other study ID #: NL37147.029.11
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: November 24, 2014
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Red Wine Polyphenols 600mg/day

• placebo

Locations

Country	Name	City	State
Netherlands	VUMedicalCenter	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity as determined by euglycemic clamp tests		8 weeks	No
Secondary	Molecular mechanisms in muscle tissue		8 weeks	No
Secondary	Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test		8 weeks	No
Secondary	microvascular function (baseline and during hyperglycemia)		8 weeks	No
Secondary	Blood pressure 24 hr measurement		8 weeks	No