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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antje Weseler, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00742287
First received: August 26, 2008
Last updated: October 28, 2011
Last verified: October 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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:
Proanthocyanidin
Procyanidin
Anti-Infective Agents
Antioxidants
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014