Effects of Microencapsulated Propolis and Turmeric in Patients With Chronic Kidney Disease

NCT05183737 | Active Not Recruiting DMC

• 1 other identifier: DeniseMafra13
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way that they bring several harms to patients, including an increased risk of cardiovascular disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in some foods seem to mitigate inflammation. Turmeric and propolis are foods that have compounds with antioxidant and anti-inflammatory capacity, as they promote the activation of nuclear erythroid transcription factor 2 (Nrf2 - responsible for the synthesis of antioxidant enzymes) and inhibit the activity of nuclear factor Kappa B (NF-κB - which increases the synthesis of inflammatory cytokines). This work aims to evaluate the effects of supplementation of associated propolis and turmeric microcapsules on inflammatory markers in patients with CKD undergoing hemodialysis (HD).

Conditions

Chronic Kidney Diseases; Inflammation

Keywords

Chronic Kidney Disease; Hemodialysis; Microcapsules; Inflammation; Propolis; Turmeric

Outcome Measures

Primary Outcomes (2)

• The effects of the supplementation on the expression of transcription factors

  Obtain blood samples to assess the effects of supplementation on biomarkers related to inflammation and antioxidant capacity, such as: erythroid nuclear transcription factor 2 (Nrf2) and nuclear factor Kappa B (NF-κB)

  4 months

• The effects of the supplementation on inflammatory cytokines

  Get blood samples to evaluate the supplementation effects on cytokines (IL-6, TNF-α)

  4 months

Secondary Outcomes (1)

• The effects of supplementation on CRP levels

  4 months

Study Arms (2)

Microcapsules with turmeric and propolis

ACTIVE COMPARATOR

Participants will receive microcapsules containing 0.250 milligrams of turmeric 95% curcumin and 0.250 milligrams of green propolis

Dietary Supplement: Microcapsules with turmeric and propolis

Placebo Group

PLACEBO COMPARATOR

Participants will receive microcapsules containing arabic gum and cornstarch with the same weight and characteristics as the intersecting microcapsules

Dietary Supplement: Microcapsules with turmeric and propolis

Interventions

Microcapsules with turmeric and propolis DIETARY_SUPPLEMENT

Participants will receive microcapsules containing 0.250 milligrams of turmeric 95% curcumin and 0.250 milligrams of green propolis, twice a day for 12 weeks

Microcapsules with turmeric and propolis; Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stage 5 CKD (GFR \< 15 mL/min);
• On hemodialysis for more than 6 months;
• Who have arteriovenous fistula (AVF) as vascular access

You may not qualify if:

• Pregnant women;
• Smokers;
• Using antibiotics in the last 3 months;
• Using antioxidant supplements;
• Who have habitual intake of propolis, curcumin and turmeric;
• With autoimmune and infectious diseases, cancer, liver and AIDS (Acquired Immunodeficiency Syndrome)

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

Capsules; Curcumin; 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)

Dosage Forms; Pharmaceutical Preparations; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a longitudinal randomized, double-blind, placebo-controlled clinical trial with patients with CKD undergoing hemodialysis. Patients will be randomized and divided into two groups: intervention group, which will receive microcapsules containing 250mg of propolis and 250mg of turmeric, twice a day, for 12 weeks, and placebo group, which will receive for the same amount of capsules containing arabic gum and cornstarch.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: January 11, 2022
• Study Start: March 7, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)