Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Hypertension; Cardiovascular Diseases
• Interventions: Dietary Supplement: Propolis + Royal Jelly; Dietary Supplement: Placebo; Dietary Supplement: Royal Jelly

• Registration Number: NCT06288204
• Lead Sponsor: Universidade Federal Fluminense

Brief Summary

This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with chronic kidney diseases (CKD) and Systemic arterial hypertension (SAH), in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.

Detailed Description

Propolis and royal jelly are bee products. Propolis is a resinous mixture produced by bees with their saliva and the addition of wax, from exudates collected from buds and plant sap. Royal jelly is a substance produced in the hypopharyngeal glands of young worker bees. Both products are rich in bioactive compounds such as polyphenols. The combination of propolis extract and royal jelly, substances constituted by the combination of several chemical components with potential biological activity, may emerge as a promising adjuvant therapeutic alternative for patients with CKD and SAH.

Study Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Status Verified: 2024-07
• Study Start: 2024-10-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• patients in stages 3 and 5 of CKD (GFR from 15 to 59 mL/min),
• patients receiving ambulatorial nutrition treatment at least 6 months
• patients on regular Hemodialysis treatment for at least 6 months
• patients using one to three antihypertensive drugs

Exclusion Criteria

• autoimmune and infectious diseases,
• diabetes
• cancer
• AIDS
• pregnant women
• patients using catabolic drugs or antibiotics;
• patients with catheter access to hemodialysis;
• patients using antioxidant vitamin supplements, prebiotics, probiotics, symbiotic,
• Patients on regular intake of propolis who are allergic to corn starch or report being allergic to bee stings.
• patients with acute myocardial infarction (AMI) and/or cerebrovascular accident (CVA)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propolis+Royal Jelly	Propolis + Royal Jelly	4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis, for 2 months.
Placebo	Placebo	4 capsules a day of placebo.
Royal Jelly	Royal Jelly	Conservative Group will receive 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.

Primary Outcome Measures

Name	Time	Method
Change in intestinal microbiota	Baseline and 8 weeks (2 months)	Stool samples will be collected to evaluate the taxa of bacteria colonizing the intestinal microbiota through short-read sequencing of the V4 region of the RNA ribosomal (rRNA) gene on the Illumina platform.
Change in factor nuclear kappaB	Baseline and 8 weeks (2 months)	Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.

Secondary Outcome Measures

Name	Time	Method
Change in senescence biomarkers	Baseline and 8 weeks (2 months)	Get blood samples to evaluate the supplementation effects in p14, p16, p21, p53.
Change in uremic toxins	Baseline and 8 weeks (2 months)	Get blood samples to evaluate the supplementation effects in p-cresyl sulfate (p-CS)

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de janeiro, RJ, Brazil