The Effects of Red Wine Polyphenols on Microvascular Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- insulin sensitivity as determined by euglycemic clamp tests
研究概览
简要总结
Rationale:
Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce
Objective:
To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.
Study design:
Randomized controlled trial (double blind).
Study population:
Obese (BMI >30); n=30, men or women, aged 18-60 years.
Intervention:
Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •age 18-60 years
- •obese (BMI >30)
排除标准
- •cardiovascular disease
- •diabetes mellitus
- •recent history (<12 months) of high alcohol use > 4 U/day
- •use of medication potentially affection insulin sensitivity or microvascular function
- •pregnancy
结局指标
主要结局
insulin sensitivity as determined by euglycemic clamp tests
时间窗: 8 weeks
次要结局
- Blood pressure 24 hr measurement(8 weeks)
- Molecular mechanisms in muscle tissue(8 weeks)
- Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test(8 weeks)
- microvascular function (baseline and during hyperglycemia)(8 weeks)
研究者
Erik Serne
MD phd
Amsterdam UMC, location VUmc