Resveratrol's Effects on Inflammation and Oxidative Stress in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02433925
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
Universidade Federal Fluminense

Brief Summary:
Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic compound with recognized antioxidant and anti-inflammatory properties, can play an important role in the control of metabolic disorders associated with CKD, since it can modulate the mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of promoting the activation of the transcription-related factor-2 nuclear factor erythroid factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein also associated with the reduction of inflammation. These two factors, in their turn, are able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription factor that participates in the inflammatory response. Although it is a promising treatment, there are no studies evaluating the effects of resveratrol supplementation in patients with CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on inflammation and oxidative stress in patients undergoing conservative treatment of CKD.

Condition or disease Intervention/treatment Phase
Chronic Renal Insufficiency Dietary Supplement: Resveratrol Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Supplementation With Resveratrol on Inflammation and Oxidative Stress of Non-dialysis Chronic Kidney Disease Patients
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Active Comparator: Supplement B
Administration of 500mg of trans-resveratrol per day, for 4 weeks
Dietary Supplement: Resveratrol
Other Name: trans-resveratrol

Placebo Comparator: Supplement A
Administration of 500mg of placebo per day, for 4 weeks
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Antioxidants and anti-inflammatory biomarkers [ Time Frame: 4 weeks ]
    Get blood samples to evaluate the supplementation effects in antioxidants biomarkers (Nrf2, GPx, HO-1)

Secondary Outcome Measures :
  1. Inflammatory biomarkers [ Time Frame: 4 weeks ]
    Get blood samples to evaluate the supplementation effects in inflammatory biomarkers (NFkB, IL-6, TNF-alfa)

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

Inclusion Criteria:

  • Chronic kidney disease patients in stages 3 or 4, undergoing conservative treatment

Exclusion Criteria:

  • Patients with diabetes mellitus, AIDS, inflammatory or infectious diseases, pregnant women, smokers and those using antioxidant supplements

Responsible Party: Universidade Federal Fluminense Identifier: NCT02433925     History of Changes
Other Study ID Numbers: DeniseMafra
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015

Keywords provided by Universidade Federal Fluminense:
oxidative stress

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