Effects of Royal Jelly Supplementation in Chronic Kidney Disease

NCT06438445 | Recruiting

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Failure, Chronic; Oxidative Stress; Hemodialysis

Keywords

Cellular Senescence; Renal Dialysis; Renal Insufficiency, Chronic; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory biomarkers

  Changes in 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, which will be evaluated from peripheral blood mononuclear cells.

  6 weeks

Study Arms (2)

Real Jelly Group

EXPERIMENTAL

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

Dietary Supplement: Real Jelly

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Real Jelly DIETARY_SUPPLEMENT

Participants will receive 500mg of royal jelly capsules per day for two months.

Real Jelly Group

Placebo DIETARY_SUPPLEMENT

Participants will receive 500mg of placebo capsules per day for two months.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with CKD undergoing hemodialysis for more than 6 months
• patients with arteriovenous fistula (AVF) as vascular access.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Mafra

  Universidade Federal Fluminense

  STUDY DIRECTOR

Central Study Contacts

Denise Mafra

CONTACT

21985683003; dmafra30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: July 30, 2024
• Primary Completion: December 22, 2025
• Study Completion: April 5, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

BR (1)