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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288204
• Other study ID #: Denise Mafra16
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: February 2024
• Source: Universidade Federal Fluminense
• Contact: Denise Mafra, PhD
• Phone: 5521985683003
• Email: dmafra30[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 153
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Propolis + 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, for 2 months.
• Royal Jelly
The participants will consume 4 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
• Placebo
The participant will consume 4 capsules a day of placebo, for 2 months.

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro	RJ

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal Fluminense	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in adhesion molecules	Get blood samples to evaluate the supplementation effects Vascular Cell Adhesion Molecule (VCAM).	Baseline and 8 weeks (2 months)
Other	Change in blood pressure	Evaluate at baseline and 8 weeks the Systolic or Diastolic Blood Pressure	Baseline and 8 weeks (2 months)
Primary	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)
Primary	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	Change in senescence biomarkers	Get blood samples to evaluate the supplementation effects in p14, p16, p21, p53.	Baseline and 8 weeks (2 months)
Secondary	Change in uremic toxins	Get blood samples to evaluate the supplementation effects in p-cresyl sulfate (p-CS)	Baseline and 8 weeks (2 months)