Effects of Royal Jelly Supplementation in Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Real Jelly, Placebo.
- Who it may be relevant to
- Registry conditions: Kidney Failure, Chronic, Oxidative Stress, Hemodialysis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis
Overview
The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).
Detailed description
Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed.
Interventions
- Dietary supplement Real Jelly
Participants will receive 500mg of royal jelly capsules per day for two months. - Dietary supplement Placebo
Participants will receive 500mg of placebo capsules per day for two months.
Primary outcome measures
- Change in inflammatory biomarkers [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- patients with CKD undergoing hemodialysis for more than 6 months
- patients with arteriovenous fistula (AVF) as vascular access.
Exclusion criteria
- pregnant,
- lactating,
- smoker
- patients using antibiotics and antioxidant supplements in the last three months
- patients with autoimmune and infectious diseases,
- patients with cancer, liver disease, and AIDS
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
Brazil · 1 center
- Denise Mafra — Rio de Janeiro
Identifiers
NCT: NCT06438445 · Interventional