Skip to main content
OpenTrials
Completed

NCT Number: NCT00742287

Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Behavior Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

Dietary Supplement

200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks

Placebo

Dietary Supplement

placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Plasma nitrite and nitrate levels

    Time frame: before start of intervention, after 4 and 8 weeks of intervention

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: INC001

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2008
Registry last updated
Nov 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.