Clinical trial NCT06288204: Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Hypertension
Cardiovascular Diseases
Keywords: chronic kidney disease
hypertension
cardiovascular disease
inflammation
oxidative stress
green propolis
royal jelly
Nrf2
Nuclear factor kappa-B
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2024-03-01
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in factor nuclear kappaB
timeFrame: Baseline and 8 weeks (2 months)
measure: Change in intestinal microbiota
timeFrame: Baseline and 8 weeks (2 months)
Secondary outcomes:
measure: Change in senescence biomarkers
timeFrame: Baseline and 8 weeks (2 months)
measure: Change in uremic toxins
timeFrame: Baseline and 8 weeks (2 months)
Other outcomes:
measure: Change in adhesion molecules
timeFrame: Baseline and 8 weeks (2 months)
measure: Change in blood pressure
timeFrame: Baseline and 8 weeks (2 months)
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
city: Rio de janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
affiliation: Universidade Federal Fluminense
name: Denise Mafra, PhD
role: PRINCIPAL_INVESTIGATOR
References: