NCT00742287: INC001

The Effects of Oligomeric Procyanidins (OPCs) on Vascular Function, Biomarkers of Oxidative Stress and Inflammation in Smokers: a Pilot Study

Completed NA Last updated 28 October 2011

What this trial tests

NA trial testing oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) in Smoking in 28 participants. Completed in 1 November 2009.

Timeline

1 February 2009

Primary endpoint
1 November 2009

1 November 2009

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	28
Start date	1 February 2009
Primary completion	1 November 2009
Estimated completion	1 November 2009
Sites	1 location across Netherlands

Drugs / interventions tested

• oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
• Placebo

Conditions studied

• Smoking — all drugs for Smoking →

Sponsor

Maastricht University Medical Center

Who can join

Adults 30 to 60, male only, with Smoking. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Vasoreactivity of conduit arteries by means of flow mediated dilation (FMD)
  Time frame: before start of intervention and at the end of the 8 week of intervention

Sponsor's own description

Smoking has been identified as a key risk factor for the development of cardiovascular diseases (CVD). It was found that a persistent increase in levels of oxidative stress and prolonged inflammation play a pivotal role in the pathogenesis of smoking associated CVD. Oligomeric proanthocyanidins (OPCs) are widely known for their anti-oxidant and anti-inflammatory effects, in vitro and in vivo. However, there are hardly any studies available that systematically investigated their acute and long-term effects on vascular function as well as on established biomarkers of oxidative stress and inflammation in an "at risk" population such as smokers.

Therefore, the aim of the present study is to investigate the effects of an eight-week supplementation with OPCs on vascular function as well as biomarkers of oxidative stress and inflammation in blood of smokers.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proanthocyanidins and hydrolysable tannins: occurrence, dietary intake and pharmacological effects.
   Smeriglio A, Barreca D, Bellocco E, Trombetta D. · · 2017 · cited 323× · PMID 27646690 · DOI 10.1111/bph.13630
2. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.
   Weseler AR, Ruijters EJ, Drittij-Reijnders MJ, Reesink KD, et al · · 2011 · cited 54× · PMID 22174811 · DOI 10.1371/journal.pone.0028460
3. Dietary flavanols modulate the transcription of genes associated with cardiovascular pathology without changes in their DNA methylation state.
   Milenkovic D, Vanden Berghe W, Boby C, Leroux C, et al · · 2014 · cited 39× · PMID 24763279 · DOI 10.1371/journal.pone.0095527
4. Oligomeric Proanthocyanidins: An Updated Review of Their Natural Sources, Synthesis, and Potentials.
   Nie F, Liu L, Cui J, Zhao Y, et al · · 2023 · cited 32× · PMID 37237870 · DOI 10.3390/antiox12051004