Status:
COMPLETED
Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Smoking
Eligibility:
MALE
30-60 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- healthy male subjects smoking ≥ 10 cigarettes per day with a regular smoking history of ≥ 5 years
- BMI ≥ 20 and ≤ 27 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00742287
Start Date
February 1 2009
End Date
November 1 2009
Last Update
November 1 2011
Active Locations (1)
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1
Maastricht University
Maastricht, Netherlands, 6200 MD