Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers
Ključne riječi
Sažetak
Datumi
| Posljednja provjera: | 09/30/2011 |
| Prvo podneseno: | 08/25/2008 |
| Predviđena prijava predata: | 08/25/2008 |
| Prvo objavljeno: | 08/26/2008 |
| Zadnje ažuriranje poslato: | 10/27/2011 |
| Posljednje ažuriranje objavljeno: | 10/31/2011 |
| Stvarni datum početka studija: | 01/31/2009 |
| Procijenjeni datum primarnog završetka: | 10/31/2009 |
| Predviđeni datum završetka studije: | 10/31/2009 |
Stanje ili bolest
Intervencija / liječenje
Dietary Supplement: 2
Dietary Supplement: 1
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| 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 |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 30 Years To 30 Years |
| Polovi podobni za studiranje | Male |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | 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 |
Ishod
Primarne mjere ishoda
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]
Sekundarne mjere ishoda
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]
