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NCT06438445 Clinical Trial

Effects of Royal Jelly Supplementation in Chronic Kidney Disease

Oxidative Stress Clinical Trial

Official title:
Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06438445
Other study ID # Interventional
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2024
Est. completion date December 5, 2024

Study information
Verified date May 2024
Source Universidade Federal Fluminense
Contact Denise Mafra
Phone 21985683003
Email dmafra30@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 5, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Real Jelly
Participants will receive 500mg of royal jelly capsules per day for two months.
• Placebo
Participants will receive 500mg of placebo capsules per day for two months.

Locations
Country Name City State
Brazil Denise Mafra Rio de Janeiro RJ

Sponsors (1)
Lead Sponsor Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in inflammatory biomarkers The mRNA levels of Nrf2, Keap1, Bach1, NLPR3, NF-kB, HO-1, NQO1, p14, p16, p21 and p53 as well as VCAM, ICAM and E-selectin and TLR-4, TNFR and AhR receptors will be evaluated from peripheral blood mononuclear cells. 6 weeks
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