The effects of oligomeric procyanidins (OPCs) on vascular function, biomarkers of oxidative stress and inflammation in smokers: a pilot study

Completed

Conditions: systemische inflammatie en oxidatieve stress
oxidative stress
systemic inflammation
10047066

Registration Number: NL-OMON33877

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

Male subjects in an age of 30-60 years
smoking of 10 and more cigarettes/d and a regular smoking history of >= 5 years
BMI >= 20 and <= 27 kg/m2
Normal hemogram and normal blood levels of glucose, creatinine, albumin, ALAT, gamma-GT, AP, bilirubin (total)
No reported acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis etc. and/or indicated by a CRP > 3.0 mg/dl
Serum cholesterol levels <= 7 mmol/L and triglycerides <= 2.5 mmol/L
No reported physical and/or mental disease(s) or major surgery that might limit participation in or completion of the study
No reported malignancy
No reported current or previous metabolic (e.g. diabetes type I/II), cardiovascular and/or renal diseases
No vegetarian or vegan lifestyle

Exclusion Criteria

Intolerance of investigational products
Occurrence of (serious) adverse events, in particular those which require the use of
- Laxatives, anti-diarrhoeal drugs and any other medication that might influence the uptake of the investigational product
- Antibiotics
- Local and systemic steroidal (glucocorticoids) and non-steroidal anti-inflammatory drugs (NSAID)
- Statines
- Blood pressure lowering/elevating drugs
- Drugs with influence on lipid and glucose metabolism
Excessive alcohol consumption (> 28 consumptions (approx. 250 g alcohol) per week)
Deviations from their usual lifestyle and physical activity habits

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter will be the alteration of the vasoreactivity of conduit<br /><br>arteries (brachial artery) by means of flow mediated dilation (FMD) and the<br /><br>endothelium-dependent en -independent reactivity of microvasculature by means<br /><br>of Laser Doppler flowmetry (LDF) after local application of ACh, L-NMMA and SNP<br /><br>by iontophoresis. </p><br>

Secondary Outcome Measures