Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers (INC001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antje Weseler, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00742287
First received: August 26, 2008
Last updated: October 28, 2011
Last verified: October 2011

August 26, 2008
October 28, 2011
February 2009
November 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Endothelium-dependent vasodilation of resistant arteries assessed by means of forearm blood flow (FBF) measurements [ Time Frame: before start of intervention and at the end of the 8 week of intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00742287 on ClinicalTrials.gov Archive Site
  • Endothelium-dependent and -independent reactivity of microvasculature by means of Laser Doppler flowmetry (LDF) [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Plasma nitrite and nitrate levels [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Systemic oxidative stress markers such as plasma levels of PGF2alpha and TEAC, GSH erythrocyte levels and gene expression of redox enzymes [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Systemic inflammation markers such as plasma levels of hsCRP, fibrinogen and cytokines, as well as gene expression levels of the latter [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Vasoreactivity of conduit arteries by means of flow mediated dilation (FMD) [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Endothelium-dependent and -independent reactivity of microvasculature by means of Laser Doppler flowmetry (LDF) [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Plasma nitrite and nitrate levels [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Systemic oxidative stress markers such as plasma levels of PGF2alpha and TEAC, GSH erythrocyte levels and gene expression of redox enzymes [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
  • Systemic inflammation markers such as plasma levels of hsCRP, fibrinogen and cytokines, as well as gene expression levels of the latter [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers
The Effects of Oligomeric Procyanidins (OPCs) on Vascular Function, Biomarkers of Oxidative Stress and Inflammation in Smokers: a Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Smoking
  • Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
    200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks
  • Dietary Supplement: Placebo
    placebo
  • Placebo Comparator: 1
    placebo
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: 2
    200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
    Intervention: Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
Weseler AR, Ruijters EJ, Drittij-Reijnders MJ, Reesink KD, Haenen GR, Bast A. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study. PLoS One. 2011;6(12):e28460. doi: 10.1371/journal.pone.0028460. Epub 2011 Dec 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy male subjects smoking ≥ 10 cigarettes per day with a regular smoking history of ≥ 5 years
  • BMI ≥ 20 and ≤ 27 kg/m2

Exclusion Criteria:

  • Occurence of any adverse event, in particular those which require the use of medication that might interfere with the effects and/or the uptake of the investigational products
  • Intolerance of study products
  • Occurence of a serious adverse event
  • Use of supplements, functional foods and/or other products containing vitamins, antioxidants and polyphenolic compounds or other ingredients with potential influence on vessel function for at least one month before the beginning of the study and during the entire study
  • Use of a medically prescribed diet or slimming diet
  • Vegetarian or vegan lifestyle
  • Excessive alcohol consumption (< 28 consumptions (approximately 250 g alcohol) per week)
  • Participation in a clinical trial within 4 weeks before the study
  • Non-compliance with the demands of the study
Male
30 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00742287
MEC 083056
No
Antje Weseler, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Antje R Weseler, PhD Maastricht University
Study Chair: Aalt Bast, PhD, Prof. Maastricht University
Maastricht University Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP