Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo | Dietary Supplement: Placebo<br>* placebo<br>|
| Active Comparator: 2<br>200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) | Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)<br>* 200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, oligomeric proanthocyanidins, polyphenols, supplementation, vascular function, oxidative stress, inflammation