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

Effects of Supplementation With Microcapsules of Tumeric and Propolis on Inflammatory Markers in Patients on Hemodialysis

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Chronic Kidney Diseases
• Intervention / Treatment: Dietary supplement: Microcapsules with turmeric and propolis

Detailed Description

The so-called Chronic Non-Communicable Diseases (NCDs) have been increasing in incidence. Among these, one can mention Chronic Kidney Disease (CKD). CKD is considered a public health problem and is characterized by an irreversible syndrome resulting from changes in the function or structure of the kidney, which has a progressive evolution.

Oxidative stress is one of the most potent inducers of inflammation, being an imbalance between the production of reactive oxygen species (ROS) and cellular antioxidant capacity, so that such imbalance can influence the activation of the nuclear factor kB (NF-κB), inflammation-associated interleukins, and tumor necrosis factor alpha 4 (TNF-α), which are promoters of cell damage and organic molecules. Patients with CKD on HD showed increased expression of NF-κB and reduced expression of Nrf2, so it is important to perform studies that propose ways to increase the performance of Nrf2, as well as reduce the activation of NF-κB. the performance of propolis and turmeric.

The study aims to evaluate the effects of supplementation of propolis and turmeric microcapsules on inflammatory markers and clinical parameters in patients with chronic kidney disease undergoing hemodialysis.

Sample calculation was performed using the G-Power 3.1 software, with a test power of 80%, considering the expression of NF-κB as the main outcome, significance level of 5% (two-tailed), effect size of 1, 32. The sample obtained consisted of 34 patients (17 in each group).

The proposed clinical study is a longitudinal randomized and double-blind (randomized controlled trial - RCT) where patients will receive capsules containing microencapsulated turmeric and propolis, twice a day, for 12 weeks. The mixture of microcapsules of propolis and turmeric will be distributed to participants in the form of hard gelatine capsules. The placebo group will receive the same amount of capsules, at the same times, containing gum arabic and corn starch. Randomization will be computerized in a 1:1 ratio.

• Anthropometric assessments, food intake, blood collections will be performed at the beginning of the follow-up and in subsequent consultations;
• The analysis of possible adverse effects will be collected through a separate analysis form;
• The assessment of food intake will be performed through the 3-day 24-hour recall;
• The assessment of nutritional status will be performed using anthropometric data;
• Blood samples will be collected in the morning, after fasting for 12 hours, before the dialysis procedure;
• NF-κB expression will be analyzed by means of peripheral blood nuclear cells (PBMCs) using real-time quantitative polymerase chain reaction (qPCR);
• For the measurement of inflammatory cytokines IL-6 and TNF-α, commercial ELISA kits will be used;
• C-reactive protein (CRP) will be determined by chemiluminescence;
• Lipid peroxidation will be estimated by determining thiobarbituric acid reactive substances (TBARS), including MDA, using the modified Ohkawa method;
• The evaluation of the total antioxidant capacity of the plasma will be determined by ELISA;

The effect of supplementation (∆) on each variable will be defined as the subject of the difference between the variable at the end of supplementation with propolis and turmeric and the value of the variable at the end of placebo administration. Statistical analyzes will be performed using SPSS version 22.0.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22260050
      • Denise Mafra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microcapsules with turmeric and propolis; 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; 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
Placebo Comparator: Placebo Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effects of supplementation on CRP levels	Measure before and after supplementation the levels of C-Reactive Protein (mg/dL)	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): March 7, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Chronic Kidney Disease; Turmeric; Hemodialysis; Propolis; Microcapsules
• 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: DeniseMafra13

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