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OpenTrials
Completed

NCT Number: NCT04411758

Propolis for Patients With Chronic Kidney Disease.

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denise Mafra

Niterói, Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propolis

Dietary Supplement

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

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

Primary outcomes

  1. Change in cytokines plasma levels measured by ELISA after supplementation with propolis.

    Time frame: 4 months

    IL-6, Tumor necrosis factor (TNF)

  2. Change the expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome, peroxisome proliferator-activated receptor-γ

    Time frame: 4 months

    nuclear factor (NF)-kappa B

  3. Change the profile of the intestinal microbiota of stool samples

    Time frame: 4 months

    uremic toxins

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2020
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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