Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers (INC001)

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6200 MD
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Antje R Weseler, PhD, Maastricht University; Study Chair: Aalt Bast, PhD, Prof., Maastricht University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: August 26, 2008
• First Submitted That Met QC Criteria: August 26, 2008
• First Posted (ESTIMATE): August 27, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2011
• Last Update Submitted That Met QC Criteria: October 28, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: smoking; inflammation; supplementation; vascular function; oxidative stress; polyphenols; oligomeric proanthocyanidins
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Protective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Proanthocyanidin; Procyanidin
• Other Study ID Numbers: MEC 083056