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Propolis for Patients With Chronic Kidney Disease.

NCT04411758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-26

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Propolis

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

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

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Denise Mafra, phd · Universidade Federal Fluminense

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2023-12-29
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411758 on ClinicalTrials.gov