Propolis for Patients With Chronic Kidney Disease.

Propolis as a New Strategy in Modulating Inflammation in Patients With Chronic Kidney Disease.

To evaluate the effects of propolis extract on inflammation in participants with chronic kidney disease.

Specific objectives

To assess before and after the intervention period:

• The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome proliferator-activated receptor-γ, as well as the levels of inflammatory cytokines (IL-6, Tumor nuclear factor-α, C-reactive protein, interleukin 1) and E-selectin adhesion molecules;
• The levels of protein expression of inflammatory markers and antioxidant enzymes;
• The profile of the intestinal microbiota of stool samples from the research participants;
• Plasma levels of substances reactive to thiobarbituric acid and oxidized low density lipoprotein as a marker of oxidative stress;
• Routine and anthropometric laboratory variables, indicative of the metabolic profile of the research participants;
• Assess blood pressure, 6-minute walk test, recovery heart rate and chair lift test to assess the functional capacity of the research participants;
• Assess atherogenic risk;
• Food intake and nutritional status; Compare data between the intervention and control groups.

Study Overview

• Status: Completed
• Conditions: Inflammation; Chronic Kidney Diseases
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Propolis

Detailed Description

Chronic kidney disease (CKD) has chronic systemic inflammation as an important component of multifactorial origin, a factor related to both the progression and outcomes of CKD, being involved in all causes of mortality in these patients, such as cardiovascular disease. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation, starting from the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation and oxidative stress, factors that feed on each other. In view of this scenario, propolis, a substance made up of a combination of several chemical components with broad potential biological activity, appears as a promising alternative to modulate inflammation in patients with CKD. However, clinical evidence to assess the effects of propolis in patients with CKD is scarce, and there are no studies that have investigated its effects on gene expression and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of propolis alcoholic extract on transcription factors and inflammatory markers in patients with CKD.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denise Mafra, PhD; Phone Number: 5521985683003; Email: dmafra30@gmail.com

Study Locations

• Brazil
  • Rio De Janeiro
    • Niterói, Rio De Janeiro, Brazil
      • Denise Mafra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older

- with fistula arteriovenous

Exclusion Criteria:

• Patients pregnant
• Smokers
• Using antibiotics in the last three months
• Using antioxidant supplements as antioxidant vitamins, probiotic, prebiotic, symbiotic and antibiotics in the last three months
• Clinical diagnosis of infectious diseases
• Clinical diagnosis of Cancer
• Clinical diagnosis of AIDS - for PD patients - no peritonitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Patients will receive 4 capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months	Dietary supplement: Placebo; Four capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months and after washout, more two months crossover
Experimental: Propolis Group; Patients will receive 4 capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months	Dietary supplement: Propolis; Four capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months and after washout, more two months crossover

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cytokines plasma levels measured by ELISA after supplementation with propolis.	IL-6, Tumor necrosis factor (TNF)	4 months
Change the expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome, peroxisome proliferator-activated receptor-γ	nuclear factor (NF)-kappa B	4 months
Change the profile of the intestinal microbiota of stool samples	uremic toxins	4 months

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Denise Mafra, PhD, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; inflammation; propolis; non-dialysis
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Anti-Infective Agents; Propolis
• Other Study ID Numbers: Denise Mafra8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No