Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Diana Jalal
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- % Change of Brachial Artery Flow-mediated Dilation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Diana Jalal
Associate Professor
University of Iowa
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
% Change of Brachial Artery Flow-mediated Dilation
Time Frame: 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
Secondary Outcomes
- Change in oxLDL(6 weeks)