NCT01518764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

2.5 years

First QC Date

January 2, 2012

Last Update Submit

November 24, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity as determined by euglycemic clamp tests

    8 weeks

Secondary Outcomes (4)

  • 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

  • Blood pressure 24 hr measurement

    8 weeks

Study Arms (2)

Red Wine Polyphenols

EXPERIMENTAL

Red Wine Polyphenols 600mg/day (capsules)

Dietary Supplement: Red Wine Polyphenols 600mg/day

placebo

PLACEBO COMPARATOR

placebo (capsules)

Dietary Supplement: placebo

Interventions

Red Wine Polyphenols 600mg/dayDIETARY_SUPPLEMENT
Also known as: Provinols™
Red Wine Polyphenols
placeboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian
  • age 18-60 years
  • obese (BMI \>30)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VUMedicalCenter

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28643477DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Erik Serne, MD PhD

    VUmc, internal medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD phd

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 26, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

NL(1)