Propolis for Patients With Chronic Kidney Disease.

NCT04411758 | Completed

• 1 other identifier: Denise Mafra8
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Inflammation

Keywords

chronic kidney disease; non-dialysis; propolis; inflammation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Patients will receive 4 capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months

Dietary Supplement: Placebo

Propolis Group

EXPERIMENTAL

Patients will receive 4 capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months

Dietary Supplement: Propolis

Interventions

Propolis DIETARY_SUPPLEMENT

Four capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months and after washout, more two months crossover

Propolis Group

Placebo DIETARY_SUPPLEMENT

Four capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months and after washout, more two months crossover

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older
• \- with fistula arteriovenous

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Niterói, Rio de Janeiro, Brazil

Location

Related Publications (3)

• Fonseca L, Ribeiro M, Schultz J, Borges NA, Cardozo L, Leal VO, Ribeiro-Alves M, Paiva BR, Leite PEC, Sanz CL, Kussi F, Nakao LS, Rosado A, Stenvinkel P, Mafra D. Effects of Propolis Supplementation on Gut Microbiota and Uremic Toxin Profiles of Patients Undergoing Hemodialysis. Toxins (Basel). 2024 Sep 25;16(10):416. doi: 10.3390/toxins16100416.

  PMID: 39453192 DERIVED

• Baptista BG, Fanton S, Ribeiro M, Cardozo LF, Regis B, Alvarenga L, Ribeiro-Alves M, Berretta AA, Shiels PG, Mafra D. The effect of Brazilian Green Propolis extract on inflammation in patients with chronic kidney disease on peritoneal dialysis: A randomised double-blind controlled clinical trial. Phytomedicine. 2023 Jun;114:154731. doi: 10.1016/j.phymed.2023.154731. Epub 2023 Mar 1.

  PMID: 36934668 DERIVED

• Chermut TR, Fonseca L, Figueiredo N, de Oliveira Leal V, Borges NA, Cardozo LF, Correa Leite PE, Alvarenga L, Regis B, Delgado A, Berretta AA, Ribeiro-Alves M, Mafra D. Effects of propolis on inflammation markers in patients undergoing hemodialysis: A randomized, double-blind controlled clinical trial. Complement Ther Clin Pract. 2023 May;51:101732. doi: 10.1016/j.ctcp.2023.101732. Epub 2023 Jan 26.

  PMID: 36708650 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

Propolis

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)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Denise Mafra, phd

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this clinical trial, participants with CKD undergoing hemodialysis or peritoneal dialysis will be instructed to use 4 capsules of 500mg/day containing concentrated and standardized dry green propolis extract (EPP-AF®) for 2 months or placebo (4 capsules of 500mg/day of magnesium stearate, silicon dioxide and microcrystalline cellulose) for two months, and then the groups will be crossed and will receive the same amount of propolis as the first group.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: January 12, 2021
• Primary Completion: December 29, 2023
• Study Completion: December 31, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)