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

NCT02433925 | Completed Phase 3

• 1 other identifier: DeniseMafra
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

resveratrol; oxidative stress; inflammation

Outcome Measures

Primary Outcomes (1)

• Antioxidants and anti-inflammatory biomarkers

  Get blood samples to evaluate the supplementation effects in antioxidants biomarkers (Nrf2, GPx, HO-1)

  4 weeks

Secondary Outcomes (1)

• Inflammatory biomarkers

  4 weeks

Study Arms (2)

Supplement B

ACTIVE COMPARATOR

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

Dietary Supplement: Resveratrol

Supplement A

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Also known as: trans-resveratrol

Supplement B

Placebo DIETARY_SUPPLEMENT

Supplement A

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Related Publications (1)

• 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.

  PMID: 37916745 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: May 5, 2015
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 5, 2015

Record last verified: 2015-04