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Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers

NCT ID: NCT00742287

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

2

200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

Group Type ACTIVE_COMPARATOR

oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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oligomeric proanthocyanidins (MASQUELIER'S Original OPCs)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Antje Weseler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antje R Weseler, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Aalt Bast, PhD, Prof.

Role: STUDY_CHAIR

Maastricht University

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 22174811 (View on PubMed)

Other Identifiers

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MEC 083056

Identifier Type: -

Identifier Source: org_study_id