Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers (INC001)
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ClinicalTrials.gov Identifier: NCT00742287 |
Recruitment Status :
Completed
First Posted : August 27, 2008
Last Update Posted : November 1, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | The Effects of Oligomeric Procyanidins (OPCs) on Vascular Function, Biomarkers of Oxidative Stress and Inflammation in Smokers: a Pilot Study |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
placebo
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Dietary Supplement: Placebo
placebo |
Active Comparator: 2
200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
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Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks |
- 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 ]
- 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 ]
- Plasma nitrite and nitrate levels [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ]

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742287
Netherlands | |
Maastricht University | |
Maastricht, Netherlands, 6200 MD |
Principal Investigator: | Antje R Weseler, PhD | Maastricht University | |
Study Chair: | Aalt Bast, PhD, Prof. | Maastricht University |
Responsible Party: | Antje Weseler, Principal Investigator, Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00742287 |
Other Study ID Numbers: |
MEC 083056 |
First Posted: | August 27, 2008 Key Record Dates |
Last Update Posted: | November 1, 2011 |
Last Verified: | October 2011 |
smoking oligomeric proanthocyanidins polyphenols supplementation |
vascular function oxidative stress inflammation |
Proanthocyanidin Procyanidin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |