Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers
Schlüsselwörter
Abstrakt
Termine
| Zuletzt überprüft: | 09/30/2011 |
| Zuerst eingereicht: | 08/25/2008 |
| Geschätzte Einschreibung eingereicht: | 08/25/2008 |
| Zuerst veröffentlicht: | 08/26/2008 |
| Letztes eingereichtes Update: | 10/27/2011 |
| Letztes Update veröffentlicht: | 10/31/2011 |
| Tatsächliches Startdatum der Studie: | 01/31/2009 |
| Geschätztes primäres Abschlussdatum: | 10/31/2009 |
| Voraussichtliches Abschlussdatum der Studie: | 10/31/2009 |
Zustand oder Krankheit
Intervention / Behandlung
Dietary Supplement: 2
Dietary Supplement: 1
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Placebo Comparator: 1 placebo | Dietary Supplement: 1 placebo |
| Active Comparator: 2 200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) | Dietary Supplement: 2 200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks |
Zulassungskriterien
| Altersberechtigt für das Studium | 30 Years Zu 30 Years |
| Studienberechtigte Geschlechter | Male |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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 |
Ergebnis
Primäre Ergebnismaße
1. 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]
Sekundäre Ergebnismaße
1. 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]
2. Plasma nitrite and nitrate levels [before start of intervention, after 4 and 8 weeks of intervention]
3. 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]
4. 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]
