Resveratrol and Vascular Function in CKD

• ClinicalTrials.gov Identifier: NCT03597568
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2018
• Last Update Posted: January 30, 2023
• Sponsor: Diana Jalal
• Information provided by (Responsible Party): Diana Jalal, University of Iowa

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Diseases; Endothelial Dysfunction	Dietary Supplement: Resveratrol; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects will be randomized to either receive the following intervention: placebo or resveratrol for six weeks and then after a two week washout will be assigned the alternate study drug.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: June 1, 2023
• Estimated Study Completion Date: June 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Resveratrol; Patients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening	Dietary Supplement: Resveratrol; Oral supplementation for 6 weeks
Placebo Comparator: Placebo; Patients will receive placebo pill identical in appearance and taste to the supplement	Other: Placebo; Oral supplementation for 6 weeks

Outcome Measures

Primary Outcome Measures :

1. Vascular endothelial function [ Time Frame: 6 weeks ]
   Brachial artery flow-mediated dilation
2. Functional work capacity [ Time Frame: 6 weeks ]
   6-minute walk test

Secondary Outcome Measures :

1. Oxidative stress [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• Active infection or antibiotic therapy
• Immunosuppressive therapy within the last year
• Currently partaking in another research study

Contacts and Locations

Locations

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52245

Sponsors and Collaborators

Diana Jalal

Investigators

• Principal Investigator: Diana Jalal; University of Iowa

More Information

• Responsible Party: Diana Jalal, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT03597568
• Other Study ID Numbers: 201806073
• First Posted: July 24, 2018
• Last Update Posted: January 30, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Diana Jalal, University of Iowa:

Resveratrol; Kidney Diseases; Renal Insufficiency; Diabetes; Oxidative stress; Endothelial dysfunction

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency; Resveratrol; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Enzyme Inhibitors; Platelet Aggregation Inhibitors