Clinical trial NCT01518764: The Effects of Red Wine Polyphenols on Microvascular Dysfunction
Official title: The Effects of Red Wine Polyphenols on Microvascular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: insulin sensitivity as determined by euglycemic clamp tests
timeFrame: 8 weeks
Secondary outcomes:
measure: Molecular mechanisms in muscle tissue
timeFrame: 8 weeks
measure: Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test
timeFrame: 8 weeks
measure: microvascular function (baseline and during hyperglycemia)
timeFrame: 8 weeks
measure: Blood pressure 24 hr measurement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VUMedicalCenter
state: Noord-Holland
Study officials:
affiliation: VUmc, internal medicine
name: Erik Serne, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woerdeman J, Del Rio D, Calani L, Eringa EC, Smulders YM, Serne EH. Red wine polyphenols do not improve obesity-associated insulin resistance: A randomized controlled trial. Diabetes Obes Metab. 2018 Jan;20(1):206-210. doi: 10.1111/dom.13044. Epub 2017 Aug 14.