Cardiovascular Diseases, Chronic Kidney Diseases, Hypertension
Conditions
Keywords
chronic kidney disease, hypertension, cardiovascular disease, inflammation, oxidative stress, green propolis, royal jelly, Nrf2, Nuclear factor kappa-B
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.
Interventions
DIETARY_SUPPLEMENTPropolis 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.
DIETARY_SUPPLEMENTRoyal Jelly
The participants will consume 1 capsules a day, providing daily royal jelly in an amount of 100 mg/day, for 2 months.
DIETARY_SUPPLEMENTPlacebo
The participant will consume 4 capsules a day of placebo, for 2 months.
Sponsors
Universidade Federal Fluminense
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Brazil
Contacts
CONTACTDenise Mafra, PhD
CONTACTLudmila Cardozo, PhD
PRINCIPAL_INVESTIGATORDenise Mafra, PhD
Universidade Federal Fluminense
Outcome results
None listed