Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- % Change of Brachial Artery Flow-mediated Dilation
研究概览
简要总结
The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.
详细描述
Patients with chronic kidney disease (CKD) have an exceptionally high risk for cardiovascular disease (CVD), and are 10 times more likely to die from CVD prior to requiring dialysis or kidney transplantation. Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction in CKD are a priority.
Wine intake, which is known to be rich in various polyphenolic compounds, might have a variety of health benefits. Among these polyphenols, the stilbene derivative resveratrol (RSV), a naturally occurring polyphenol found in grapes and red wine, has recently come to light, as it has been shown to exert potent anti-diabetic, anti-oxidative and anti-inflammatory actions. Importantly, recent studies have demonstrated that resveratrol is well-tolerated (37) and may confer similar benefits in individuals at high risk of CVD, such as improved endothelial function in individuals with metabolic syndrome (i.e. diabetes)
The primary goal of this application is to determine whether 6 wks resveratrol (RSV) supplementation improves vascular function by reducing oxidative stress in a randomized, double-blind, cross-over study of 25 patients with diabetic kidney disease. The investigators hypothesize that: 1) 6 wks RSV will improve vascular function as measured via BA-FMD vs. placebo and 2) that the improvement in vascular function will be related, at least partially, to a reduction in oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stage III (estimated GFR: 30-60 mL/MIN/1.73m2)
- •Able to give informed consent
- •Angiotensin converting enzyme inhibitor or angiotensin II receptor bloocker for > 3 month prior to the study
- •Type II diabetes mellitus
排除标准
- •Consuming > 2 glasses/day red wine and/or taking resveratrol or vitamin C supplement in the past 12 months
- •Life expectancy <1 year
- •BMI >40 kg/m2 1
- •Pregnant, breastfeeding, or unwilling to use adequate birth control
- •Uncontrolled hypertension; blood pressure > 140/90
- •Uncontrolled type II DM; AIC > 8.5
- •Currently taking anticoagulants including: coumadin, dalteparin, enoxaparin, haparin, and plavix.
- •Severe liver disease
- •Severe systolic heart failure
- •Hospitalization within the last 3 months
- •Active infection or antibiotic therapy
- •Immunosuppressive therapy within the last year
- •Currently partaking in another research study
研究组 & 干预措施
Resveratrol first, then placebo
Patients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening. After a minimum of 2 week washout period, subjects then took placebo for 6 weeks.
干预措施: Placebo (Other)
Placebo first, then resveratrol
Patients will receive placebo pill identical in appearance and taste to the supplement. Subjects took this placebo twice daily, once in the morning and once in the evening. After a minimum of 2 week washout period, subjects then took resveratrol for 6 weeks.
干预措施: Placebo (Other)
Placebo first, then resveratrol
Patients will receive placebo pill identical in appearance and taste to the supplement. Subjects took this placebo twice daily, once in the morning and once in the evening. After a minimum of 2 week washout period, subjects then took resveratrol for 6 weeks.
干预措施: Resveratrol (Dietary Supplement)
Resveratrol first, then placebo
Patients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening. After a minimum of 2 week washout period, subjects then took placebo for 6 weeks.
干预措施: Resveratrol (Dietary Supplement)
结局指标
主要结局
% Change of Brachial Artery Flow-mediated Dilation
时间窗: First Baseline measurement to 6 weeks then Second baseline to 6 weeks
Brachial artery flow-mediated dilation, dilation of the brachial artery in response to shear stress. Resveratrol first, then placebo: Baseline to 6 weeks on Resveratrol Minimum 2 week washout Baseline to 6 week on placebo Placebo first, then resveratrol: Baseline to 6 weeks on placebo Minimum washout 2 weeks Baseline to 6 weeks on resveratrol
次要结局
- Change in oxLDL(6 weeks)
研究者
Diana Jalal
Associate Professor
University of Iowa
