Effects of Royal Jelly Supplementation in Chronic Kidney Disease

Universidade Federal Fluminense

Status: Enrolling

Conditions: Hemodialysis; Oxidative Stress; Kidney Failure, Chronic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Real Jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT06438445

Interventional (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups, including a placebo group

Real Jelly Group

Experimental group

Description:

Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of royal jelly/day for two months.

Treatment:

Dietary Supplement: Real Jelly

Placebo group

Placebo Comparator group

Description:

Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of placebo/ day for two months.

Treatment:

Dietary Supplement: Placebo