Clinical trial NCT00742287: Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers
Official title: The Effects of Oligomeric Procyanidins (OPCs) on Vascular Function, Biomarkers of Oxidative Stress and Inflammation in Smokers: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
oligomeric proanthocyanidins
polyphenols
supplementation
vascular function
oxidative stress
inflammation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 28
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vasoreactivity of conduit arteries by means of flow mediated dilation (FMD)
timeFrame: before start of intervention and at the end of the 8 week of intervention
Secondary outcomes:
measure: Endothelium-dependent and -independent reactivity of microvasculature by means of Laser Doppler flowmetry (LDF)
timeFrame: before start of intervention, after 4 and 8 weeks of intervention
measure: Plasma nitrite and nitrate levels
timeFrame: before start of intervention, after 4 and 8 weeks of intervention
measure: Systemic oxidative stress markers such as plasma levels of PGF2alpha and TEAC, GSH erythrocyte levels and gene expression of redox enzymes
timeFrame: before start of intervention, after 4 and 8 weeks of intervention
measure: Systemic inflammation markers such as plasma levels of hsCRP, fibrinogen and cytokines, as well as gene expression levels of the latter
timeFrame: before start of intervention, after 4 and 8 weeks of intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Antje R Weseler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Aalt Bast, PhD, Prof.
role: STUDY_CHAIR
References:
citation: 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.