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

Phase 3

Completed

• Conditions: Chronic Renal Insufficiency
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Resveratrol

• Registration Number: NCT02433925
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Study First Submitted: 2015-02-19
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-29
• Last Update Submitted: 2015-04-29
• Study First Posted: 2015-05-05
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplement A	Placebo	Administration of 500mg of placebo per day, for 4 weeks
Supplement B	Resveratrol	Administration of 500mg of trans-resveratrol per day, for 4 weeks

Primary Outcome Measures

Name	Time	Method
Antioxidants and anti-inflammatory biomarkers	4 weeks	Get blood samples to evaluate the supplementation effects in antioxidants biomarkers (Nrf2, GPx, HO-1)

Secondary Outcome Measures

Name	Time	Method
Inflammatory biomarkers	4 weeks	Get blood samples to evaluate the supplementation effects in inflammatory biomarkers (NFkB, IL-6, TNF-alfa)