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

Association of Green Propolis Extract and Royal Jelly to Modulate Inflammation and Oxidative Stress in Hypertensive Patients and/or With Chronic Kidney Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension; Chronic Kidney Diseases
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Propolis associated with Royal Jelly; Dietary supplement: Royal Jelly

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 Type: Interventional
• Enrollment (Estimated): 153
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denise Mafra, PhD; Phone Number: 5521985683003; Email: dmafra30@gmail.com
• Study Contact Backup: Name: Ludmila Cardozo, PhD; Phone Number: 5521987333185; Email: ludmila.cardozo@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 22260050
      • Recruiting
      • Denise Mafra
      • Contact: Denise Mafra, phd; Phone Number: 21985683003; Email: dmafra30@gmail.com
    • Rio de Janeiro, Rio de Janeiro, Brazil
      • Recruiting
      • Denise Mafra
      • Contact: Denise Mafra; Phone Number: 5521985683003; Email: dmafra30@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 4 capsules a day of placebo.	Dietary supplement: Placebo; The participant will consume 4 capsules a day of placebo, for 2 months.
Experimental: Propolis associated with Royal Jelly Group; 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis together, for 2 months.	Dietary supplement: Propolis associated with Royal Jelly; The participants will consume 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day plus 500 mg/day of propolis together, for 2 months.
Experimental: Royal Jelly; Royal Jelly will receive 1 capsule a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.	Dietary supplement: Royal Jelly; The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in factor nuclear kappaB	Get blood samples to evaluate the supplementation effects in factor nuclear kappaB by quantitative real-time polymerase chain reaction.	Baseline and 8 weeks (2 months)
Change in intestinal microbiota	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.	Baseline and 8 weeks (2 months)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adhesion molecules	Get blood samples to evaluate the supplementation effects Vascular Cell Adhesion Molecule (VCAM).	Baseline and 8 weeks (2 months)
Change in blood pressure	Evaluate at baseline and 8 weeks the Systolic or Diastolic Blood Pressure	Baseline and 8 weeks (2 months)

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Principal Investigator: Denise Mafra, PhD, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; cardiovascular disease; chronic kidney disease; inflammation; Nrf2; oxidative stress; green propolis; royal jelly; Nuclear factor kappa-B
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Hypertension; Cardiovascular Diseases; Inflammation; Renal Insufficiency, Chronic; Anti-Infective Agents; royal jelly
• Other Study ID Numbers: Denise Mafra16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be public to other research unless necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No