Propolis for Patients With Chronic Kidney Disease.

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411758
• Other study ID #: Denise Mafra8
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Propolis
Four capsules (400mg/day) containing dry EPP-AF® green propolis extract for 2 months and after washout, more two months crossover
• Placebo
Four capsules (400mg/day) containing magnesium stearate, silicon dioxide and microcrystalline cellulose for 2 months and after washout, more two months crossover

Locations

Country	Name	City	State
Brazil	Denise Mafra	Niterói	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

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