Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438445
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
Effects of Royal Jelly Supplementation in Chronic Kidney Disease
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mLday dosing cup containing a dose equivalent to 110 mgday of standardized green propolis extract EPP-AF plus 130 mg of curcuminoidsday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None