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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
Sponsor:
Information provided by (Responsible Party):
Antje Weseler, Maastricht University Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Smoking Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) Dietary Supplement: Placebo Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
placebo
 Dietary Supplement: Placebo
placebo
Active Comparator: 2
200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
 Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Antje R Weseler, PhD Maastricht University
Study Chair: Aalt Bast, PhD, Prof. Maastricht University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Antje Weseler, Maastricht University Medical Center:
smoking
oligomeric proanthocyanidins
polyphenols
supplementation
 vascular function
oxidative stress
inflammation
Additional relevant MeSH terms:
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Proanthocyanidin
Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents