Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

NCT00742287 | Completed

• 1 other identifier: MEC 083056
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

smoking; oligomeric proanthocyanidins; polyphenols; supplementation; vascular function; oxidative stress; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

2

ACTIVE COMPARATOR

200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

Dietary Supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

Interventions

oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) DIETARY_SUPPLEMENT

200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks

2

Placebo DIETARY_SUPPLEMENT

placebo

1

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male subjects smoking ≥ 10 cigarettes per day with a regular smoking history of ≥ 5 years
• BMI ≥ 20 and ≤ 27 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

Related Publications (1)

• Weseler AR, Ruijters EJ, Drittij-Reijnders MJ, Reesink KD, Haenen GR, Bast A. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study. PLoS One. 2011;6(12):e28460. doi: 10.1371/journal.pone.0028460. Epub 2011 Dec 8.

  PMID: 22174811 DERIVED

MeSH Terms

Conditions

Smoking; Inflammation

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antje R Weseler, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Aalt Bast, PhD, Prof.

  Maastricht University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: February 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

NL (1)