Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers - Full Text View

Sponsor:	Maastricht University Medical Center
Information provided by (Responsible Party):	Antje Weseler, Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00742287

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Smoking

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Plasma nitrite and nitrate levels [ Time Frame: before start of intervention, after 4 and 8 weeks of intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	February 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742287

Locations

Netherlands
Maastricht University
Maastricht, Netherlands, 6200 MD

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator:	Antje R Weseler, PhD	Maastricht University
Study Chair:	Aalt Bast, PhD, Prof.	Maastricht University

More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Dec 8.

Responsible Party:	Antje Weseler, Principal Investigator, Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00742287 History of Changes
Other Study ID Numbers:	MEC 083056
Study First Received:	August 26, 2008
Last Updated:	October 28, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

smoking
oligomeric proanthocyanidins
polyphenols
supplementation

vascular function
oxidative stress
inflammation

Additional relevant MeSH terms:

Inflammation
Smoking
Pathologic Processes
Habits
Proanthocyanidin
Procyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012