Actively Recruiting
Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis
Led by Universidade Federal Fluminense · Updated on 2026-05-18
30
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of royal jelly on inflammation and cellular aging in patients with chronic kidney disease (CKD) who are undergoing hemodialysis. The study focuses on how bioactive compounds in royal jelly may influence inflammation and premature aging processes seen in these patients. It is a clinical, randomized, longitudinal study with a washout and crossover design to better understand these effects. Participants with CKD on hemodialysis will receive either 500 mg capsules of royal jelly daily or placebo capsules for two months. After this supplementation period, there will be an eight-week washout phase, followed by a crossover where participants switch to the other treatment for another two months. Biological samples such as blood and feces will be collected before and after each study period to analyze various markers related to inflammation, antioxidant capacity, and gut microbiota composition. During the study, researchers will assess inflammatory biomarkers, antioxidant enzyme activity, gene and protein expressions related to cellular aging, and uremic toxins from the intestinal microbiota. Nutritional status and dietary intake will also be monitored. The main outcome is the change in inflammatory biomarkers measured at six weeks. The entire study participation includes supplementation periods, washout, and sample collections to comprehensively evaluate royal jelly's effects on CKD patients on hemodialysis.
CONDITIONS
Brief Title
Effects of Royal Jelly Supplementation in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic kidney disease undergoing hemodialysis for more than 6 months
- Patients with arteriovenous fistula (AVF) as vascular access
- Age between 18 and 70 years
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Smokers
- Patients using antibiotics or antioxidant supplements in the last three months
- Patients with autoimmune or infectious diseases
- Patients with cancer, liver disease, or AIDS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take royal jelly or placebo capsules daily for two months while undergoing hemodialysis. Biological samples will be collected before and after this period to evaluate inflammation and cellular aging.
Visits aligned with hemodialysis sessions; biological sample collections before and after treatment periods
Duration - 8 weeks
Participants stop taking capsules for 8 weeks to clear the initial treatment effects before crossing over to the other treatment.
Visits aligned with hemodialysis sessions
Duration - 8 weeks
Participants take the alternate capsules (placebo or royal jelly) daily for two months. Biological samples will be collected before and after this second treatment period.
Visits aligned with hemodialysis sessions; biological sample collections before and after treatment periods
Trial Site Locations
Total: 1 location
1
Denise Mafra
Rio de Janeiro, Rio de Janeiro, Brazil, 22260050
Actively Recruiting
Research Team
D
Denise Mafra
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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