Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

• Registration Number: NCT00742287
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2009-02
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-28
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	placebo
2	oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)	200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Endothelium-dependent and -independent reactivity of microvasculature by means of Laser Doppler flowmetry (LDF)	before start of intervention, after 4 and 8 weeks of intervention
Plasma nitrite and nitrate levels	before start of intervention, after 4 and 8 weeks of intervention
Systemic oxidative stress markers such as plasma levels of PGF2alpha and TEAC, GSH erythrocyte levels and gene expression of redox enzymes	before start of intervention, after 4 and 8 weeks of intervention
Systemic inflammation markers such as plasma levels of hsCRP, fibrinogen and cytokines, as well as gene expression levels of the latter	before start of intervention, after 4 and 8 weeks of intervention

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands