Resveratrol and Vascular Function in CKD

Chronic Kidney Diseases Clinical Trial

Official title:

Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03597568
• Other study ID #: 201806073
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

• Active infection or antibiotic therapy

• Immunosuppressive therapy within the last year

• Currently partaking in another research study

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Endothelial Dysfunction
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Resveratrol
Oral supplementation for 6 weeks

Other:
• Placebo
Oral supplementation for 6 weeks

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Diana Jalal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular endothelial function	Brachial artery flow-mediated dilation	6 weeks
Secondary	Oxidative stress		6 weeks