Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

Smoking Clinical Trial

— INC001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742287
• Other study ID #: MEC 083056
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: October 28, 2011
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: October 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking

Intervention

Dietary Supplement:
• oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)
200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks
• Placebo
placebo

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Plasma nitrite and nitrate levels		before start of intervention, after 4 and 8 weeks of intervention	No
Secondary	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	No
Secondary	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	No