The Effects of Oligomeric Procyanidins (OPCs) on Vascular Function, Biomarkers of Oxidative Stress and Inflammation in Smokers: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Vasoreactivity of conduit arteries by means of flow mediated dilation (FMD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subjects smoking ≥ 10 cigarettes per day with a regular smoking history of ≥ 5 years
- •BMI ≥ 20 and ≤ 27 kg/m2
排除标准
- •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
结局指标
主要结局
Vasoreactivity of conduit arteries by means of flow mediated dilation (FMD)
时间窗: before start of intervention and at the end of the 8 week of intervention
次要结局
- 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)
- Plasma nitrite and nitrate levels(before start of intervention, after 4 and 8 weeks of intervention)
- 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)
- 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)
研究者
Antje Weseler
Principal Investigator
Maastricht University Medical Center