Propolis for Patients With Chronic Kidney Disease.

NCT ID: NCT04411758

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Chronic Kidney Diseases; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Propolis Group

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

Group Type: EXPERIMENTAL

Propolis

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Propolis

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Mafra, phd

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal Fluminense

Locations

Denise Mafra

Niterói, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39453192 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36934668 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36708650 (View on PubMed)

Other Identifiers

Denise Mafra8

Identifier Type: -

Identifier Source: org_study_id