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Resveratrol and Vascular Function in CKD

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ClinicalTrials.gov Identifier: NCT03597568
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Jalal, University of Iowa

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.


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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 : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597568


Contacts
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Contact: Katharine Geasland, Ph.D. 319-353-6318 katharine-geasland@uiowa.edu
Contact: Diana Jalal, MD 319-356-4113 diana-jalal@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52245
Contact: Katharine Geasland    319-353-6318    katharine-geasland@uiowa.edu   
Sponsors and Collaborators
Diana Jalal
Investigators
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Principal Investigator: Diana Jalal University of Iowa

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Responsible Party: Diana Jalal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03597568     History of Changes
Other Study ID Numbers: 201806073
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents