The Effects of Red Wine Polyphenols on Microvascular Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
Erik Serne, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01518764
First received: January 2, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 18-50 years.

Intervention:

Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.


Condition Intervention
Obesity
Dietary Supplement: Red Wine Polyphenols 600mg/day
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Red Wine Polyphenols on Microvascular Dysfunction

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • insulin sensitivity as determined by euglycemic clamp tests [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Molecular mechanisms in muscle tissue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Biomarkers such as lipoproteins, adipocytokines, and markers of systemic inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • microvascular function (baseline and during hyperglycemia) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure 24 hr measurement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Red Wine Polyphenols
Red Wine Polyphenols 600mg/day (capsules)
Dietary Supplement: Red Wine Polyphenols 600mg/day
Other Name: Provinols™
Placebo Comparator: placebo
placebo (capsules)
Dietary Supplement: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian
  • age 18-50 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518764

Contacts
Contact: E Serne, MD PhD e.serne@vumc.nl

Locations
Netherlands
VUMedicalCenter Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: E.H. Serne, MD PhD       e.serne@vumc.nl   
Sponsors and Collaborators
VU University Medical Center
Investigators
Principal Investigator: Erik Serne, MD PhD VUmc, internal medicine
  More Information

No publications provided

Responsible Party: Erik Serne, MD phd, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01518764     History of Changes
Other Study ID Numbers: NL37147.029.11
Study First Received: January 2, 2012
Last Updated: November 6, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014