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

NCT ID: NCT02433925

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Supplement B

Administration of 500mg of trans-resveratrol per day, for 4 weeks

Group Type: ACTIVE_COMPARATOR

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Supplement A

Administration of 500mg of placebo per day, for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

trans-resveratrol

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

Reference Type: DERIVED

PMID: 37916745 (View on PubMed)

Other Identifiers

DeniseMafra

Identifier Type: -

Identifier Source: org_study_id